Date: Thu, 30 Jan 97 14:44:07 EST From: "David Radune" Subject: New Information from ACTIS: Protocol ACTG 853 NEW INFORMATION FROM ACTIS January 30, 1997 The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of a recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ******************************************************************************* PROTOCOL NUMBER: NIAID ACTG 853. TITLE: Effects of Treatment for MAC Infection on Cytokine Expression in HIV-infected Persons. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Documented HIV infection by ELISA with Western Blot confirmation, serum p24 antigen, recovery of HIV in culture, or a diagnosis of AIDS based on the 1987 CDC criteria. 2. Patients must have either: Symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR Asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. Either symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry. 3. Signed parental consent for patients less than 18 years of age. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. PRIOR MEDICATION: Allowed: 1. Patients who have recieved presumptive or empiric antimycobacterial therapy prior to study entry may be enrolled if they have been treated for no more than 72 hours prior to study entry. 2. Patients who have been receiving prophylaxis with azithromycin, clarithromycin and/or rifabutin may be enrolled. 3. Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry. Required: 4. Patients must be on a stable antiretroviral regimen (same drug or combination drugs; dose modifications allowed) for at least 4 weeks prior to study entry. NOTE: Patients will be requested NOT to modify or add new drugs to their stable ARV regimen for the duration of this study. Patients who absolutely require ARV changes at any time prior to week 8 will continue on study, however, their data will be analyzed separately. CONCURRENT MEDICATION: Allowed: 1. Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Not specified. cells/mm3. SGOT (AST): <= 10 X ULN. (ULN = upper limit of normal) SGPT (ALT): <= 10 X ULN. CREATININE: < 2.5 X ULN. CREATININE CLEARANCE: > 30 ml/min. KARNOFSKY: >= 40. OTHER LABORATORY VALUES: Absolute neutrophil count > 500/mm3 PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions will be excluded: Subjects who have had an opportunistic infection (other than MAC) within 14 days immediately preceding study entry. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. PRIOR TREATMENT: Excluded: 1. Patients who have received a blood transfusion within the 14 days immediately preceding study entry. PRIOR MEDICATION: Excluded within the 14 days immediately preceding study entry: 1. Cytokine inhibitors. 2. Corticosteroids. 3. Thalidomide. 4. Pentoxifylline or any other immunomodulator. 5. Any interleukin. 6. Colony stimulating factors (G-CSF or GM-CSF) CONCURRENT MEDICATION: Excluded: 1. Cytokine inhibitors. 2. Corticosteroids. 3. Thalidomide. 4. Pentoxifylline or any other immunomodulator. 5. Any interleukin. 6. Colony stimulating factors (G-CSF or GM-CSF) CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Previous enrollment and permanent study drug discontinuation in ACTG 223. Note: Co-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both studies must be simultaneous. 2. This protocol does not meet federal requirements governing prisoner participation in clinical trials and should not be considered by local IRBs for the recruitment of prisoners. END POINT --------- The difference between the log of plasma TNF-alpha level at week 4 (or week 6 if the week 4 study visit is missed) and baseline using the Medgenix assay. DISCONTINUE TREATMENT --------------------- Patients may be discontinued from the study for the following reasons: 1. The patient or legal guardian refuses further participation in the study. 2. The patient or legal guardian refuses further MAC treatment. 3. the investigator determines that further participation in the study would be detrimental to the patient's health or well being. 4. The patient fails to comply with the study requirements so as to cause harm to self or seriously interfere with the validity of the study results. 5. the patient requires treatment with medications which are disallowed while on the study. NOTE: Attempts should be made to have patients who discontinue participation in this study (for any reason) prior to week 4 of week 8 to complete any remaining study visits and the evaluations. PARTICIPATING UNITS ------------------- 0000002265: University of Colorado Health Sciences Center 4200 East 9th Avenue / Colorado ACTU / Campus Box B-163 Denver, CO 80262 Contact: M Graham Ray (303) 372-5535 OPEN 970117 ACTU: 6101. 0000001303: Case Western Reserve University 2061 Cornell Road / Foley Building / Room 120 Cleveland, OH 44106-4984 Contact: Michael Chance (216) 844-8051 Contact: (216) 844-8175 OPEN 961119 ACTU: 2501. Date: Thu, 30 Jan 97 14:44:25 EST From: "David Radune" Subject: New Information from ACTIS: Protocol ACTG 329 NEW INFORMATION FROM ACTIS January 30, 1997 The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of a recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ******************************************************************************* PROTOCOL NUMBER: NIAID ACTG 329. TITLE: A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss. PHASE: Phase I / Phase II. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Documented HIV infection by any licensed ELISA test kit and confirmed by either Western Blot, HIV antigen, HIV culture or a second antibody test by method other than ELISA. 2. Documented weight loss of > 5%, or body mass index < 18.5 kg/m2 not explained by pregnancy, within the previous 12 months. 3. Able to consume >= 80% of estimated maintenance energy requirement based on current weight, as determined by diet history. NOTE: Potential patients whose energy intake is below this level will be offered nutritional counseling and the opportunity to be re-screened at a later date, or referred to for therapy with appetite stimulants. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. Documented weight loss of > 5%, or body mass index < 18.5 kg/m2. 3. Able to consume >= 80% of estimated maintenance energy requirement. NOTE: Potential patients whose energy intake is below this level will be offered nutritional counseling and the opportunity to be re-screened at a later date, or referred to for therapy with appetite stimulants. 4. Signed parental consent if < 18 years of age. NOTE: Patients under the age of 18 years will be screened for bone age and Tanner staging and must have a bone age of >= 16 years with a Tanner score of 5. 5. Subjects with Kaposi's sarcoma will be allowed, provided they have stable cutaneous lesions and do not require systemic or radiation therapy for KS. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. Negative pregnancy test. Abstinence or effective method of birth control / contraception during the study and for 30 days after. Abstinence or agree to use both barrier and hormonal methods of birth control / contraception. PRIOR MEDICATION: Required: Patients must either be receiving a stable antiretroviral therapy regimen or no antiretroviral therapy for >= 30 days prior to study entry. Patients not receiving antiretroviral therapy may enter the study as long as they agree not to initiate antiretroviral therapy during the first 12 weeks on study. LABORATORY VALUES AT ENTRY -------------------------- PLATELET COUNT: > 50,000 platelets/mm3. CD4 (T4 CELL) COUNT: Not specified cells/mm3. BILIRUBIN: < 1.5 X ULN mg/dl. (ULN = upper limit of normal) SGOT (AST): < 5 X ULN. SGPT (ALT): < 5 X ULN. KARNOFSKY: >= 60. OTHER LABORATORY VALUES: PT < 1.3 X ULN PTT within normal limits PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions will be excluded: 1. History of hypersensitivity reaction to nandrolone decanoate. 2. Patients who have ever been diagnosed withinvasive cervical cancer. 3. History of cardiomyopathy or congestive heart failure. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 12 Years. SEX: M. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. Positive pregnancy test. No abstinence or no agreement to use effective method of birth control during study and for 30 days after. No abstinence or no agreement to use both barrier and hormonal methods of birth control / contraception. CONCURRENT TREATMENT: Excluded: 1. Systemic or radiation therapy. PRIOR MEDICATION: Excluded within 30 days prior to entry: 1. Anticoagulation therapy. 2. Other anabolic therapy (anabolic steroids, growth hormone, cytokine suppressors such as thalidomide, pentoxifylline and ketotifen). 3. Total or peripheral parenteral nutrition. 4. Enteral tube feeding. 5. Appetite stimulants (dronabinol, megestrol acetate (Megace), and Periactin). 6. Interleukins. 7. Any other experimental therapies designed to improve appetite or promote weight gain. 8. Initiation of antiretroviral therapy. 9. Systemic chemotherapy. 10. Glucocorticoids. 11. Interferons. 12. Cytokine inhibitors. CONCURRENT MEDICATION: Excluded: 1. Anticoagulation therapy. 2. Other anabolic therapy (anabolic steroids, growth hormone, and testosterone). 3. Interleukins. 4. Any other drug or experimental therapies designed to affect appetite or promote weight gain (dronabinol, megestrol acetate amd Periactin). 5. Any new antiretroviral therapy or change in dosage of current antiretrovirals during the first 12 weeks on-study. 6. Systemic chemotherapeutic agents except when used for Kapos's sarcoma. 7. Systemic glucocorticoids. 8. Interferons. 9. Cytokine inhibitors (pentoxifylline and thalidomide). 10. Oral hypoglycemics. 11. Any other medication that might interfere with the objectives of the study. CO-EXISTING CONDITIONS OR DISEASES: Patients with any of the following current conditions will be excluded: 1. Active opportunistic infection or other major systemic illness within 30 days prior to entry. 2. Persistent palpable dominant breast mass at study entry which has not been worked up. 3. Invasive cervical cancer. 4. Pap smear or cervical biopsy at screening or on study which demonstrates high grade squamous intraepithelial lesions or CIN2 or worse. 5. Diabetes mellitus. 6. Cardiomyopathy or congestive heart failure. 7. Impaired oral intake. 8. >= grade 2 intractable nausea or vomiting. 9. Persistant diarrhea, defined as >= 4 stools/day while using antidiarrheal medication. 10. A condition requiring anticoagulation therapy while on study. GENERIC DRUG NAME ----------------- Drug 1: Nandrolone Decanoate. Anabolic steroid. DRUG COMPANIES -------------- Drug 1: Organon Incorporated 375 Mount Pleasant Avenue West Orange, NJ 07052 Contact: Unspecified (201) 325-4500. END POINT --------- Safety, and quality of life. DISCONTINUE TREATMENT --------------------- Patients may be discontinued from the study for the following reasons: 1. Patient or legal guardian refuses further treatment or follow up evaluations. 2. Investigator determines that further participation would be detrimental to the subject's health or well being. 3. Patient fails to comply with the study requirements so as to cause harm to self or seriously interfere with the validity of the study results. 4. Patient requires treatment with medications which are disallowed while on this study. 5. Unacceptable drug toxicity. 6. Cumulative weight loss of >= 5% from baseline value. 7. Any new malignancy other than KS. 8. Hypertension not responsive to medical management. 9. Peliosis hepatis. 10. Cervical study with CIN2 or high grade SIL or worse results. 11. Pregnancy. PARTICIPATING UNITS ------------------- 0000001400: University of Southern California / LA County USC Med Ctr 2020 Zonal Avenue / Room 309 Los Angeles, CA 90033-1079 Contact: Luis Mendez (213) 343-8288 OPEN 961211 ACTU: 1201. 0000001399: UCLA School of Medicine / UCLA CARE Center 10833 Le Conte Avenue / BH 412 - CHS Los Angeles, CA 90095-1793 Contact: Susan G McCarthy (310) 206-8029 OPEN 970121 ACTU: 0601. 0000001376: University of California / San Diego Treatment Center 2760 5th Avenue / Suite 300 San Diego, CA 92103-6325 Contact: Janice Menendez (619) 543-8080 OPEN 961227 ACTU: 0701. 0000001381: San Francisco General Hospital 995 Potrero Avenue / Building 80 / Ward 84 San Francisco, CA 94110-2859 Contact: David Gary (415) 476-9296 X 354 OPEN 961212 ACTU: 0801. 0000002265: University of Colorado Health Sciences Center 4200 East 9th Avenue / Colorado ACTU / Campus Box B-163 Denver, CO 80262 Contact: M Graham Ray (303) 372-5535 OPEN 961206 ACTU: 6101. 0000002175: Howard University 2112 Georgia Avenue NW Washington, DC 20059 Contact: Dr Yvette Butler (202) 806-4700 OPEN 970109 ACTU: 5301. 0000001346: Charity Hospital / Tulane University Medical School 1532 Tulane Avenue / 5th floor / East 505 New Orleans, LA 70112 Contact: Russell Strada (504) 584-3605 Contact: (504) 584-1692 OPEN 961212 ACTU: 1702. 0000001350: New England Deaconess Hospital One Autumn Street / Kennedy Building / 6th Floor Boston, MA 02215 Contact: Helen Fitch (617) 632-0785 OPEN 961227 ACTU: 0103. 0000001335: Washington University School of Medicine 4511 Forest Park / Suite 304 St Louis, MO 63108 Contact: Michael Klebert (314) 454-0058 OPEN 961212 ACTU: 2101. 0000001336: St Louis Regional Hospital / St Louis Regional Med Center 5535 Del Mar / West Annex / 6th Floor St Louis, MO 63112 Contact: Michael Conklin (314) 879-6412 OPEN 961212 ACTU: 2102. 0000001317: Beth Israel Medical Center First Avenue at 16th Street New York, NY 10003 Contact: Ann Marshak (212) 420-4432 OPEN 961211 ACTU: 1802. Date: Thu, 30 Jan 97 14:44:42 EST From: "David Radune" Subject: New Information from ACTIS: Protocol ACTG 313 NEW INFORMATION FROM ACTIS January 30, 1997 The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of a recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ******************************************************************************* PROTOCOL NUMBER: NIAID ACTG 313. TITLE: Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting. PHASE: Phase II. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV-1 infection, documented by the presence of antibody (ELISA with Western Blot confirmation), serum p24 antigen, recovery of HIV in culture, or a diagnosis of AIDS based on the 1993 CDC criteria. 2. Documented weight loss of > 10% pre-illness weight or Body Mass Index < 18.5 kg/m2. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV-1 infection. 2. Documented weight loss of > 10% pre-illness weight or Body Mass Index < 18.5 kg/m2. 3. Life expectancy of at least 6 months. NOTE: This protocol meets federal requirements requiring governing prisoner participation in clinical trials. [Refer to Laboratory values for additional requirements.] AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Negative pregnancy test. Not pregnant. Abstinence or agree to use barrier methods of birth control / contraception during the study. PRIOR MEDICATION: Allowed: Stable (no change in drugs or dosage) antiretroviral therapy or no antiretroviral medications for >= 30 days prior to the study entry. CONCURRENT MEDICATION: Allowed: 1. Stable antiretroviral therapy provided the patient has been on it for >=30 days prior to study entry. 2. Standard maintenance and prophylaxis therapy for opportunistic infections is permitted provided patients have been on a stable dosage regimen for 2 weeks prior to screening. 3. G-CSF. 4. Erythropoietin. 5. Any symptomatic therapy (e.g. analgesics, antihistamines, antiemetic, antidiarrheal aents, etc.). 6. Replacement levels of thyroid drugs (same drug and dose as at 30 days pre-entry). 7. Maintenance therapy is permitted for chronic opportunistic infections, but patient must be on a stable regimen for 14 days pre-entry. LABORATORY VALUES AT ENTRY -------------------------- PLATELET COUNT: > 50,000 platelets/mm3. CD4 (T4 CELL) COUNT: Not specified cells/mm3. BILIRUBIN: < 1.5 X ULN mg/dl. (ULN = upper limit of normal) SGOT (AST): < 5 X ULN. SGPT (ALT): < 5 X ULN. CREATININE: < 3 X ULN. KARNOFSKY: >= 60. OTHER LABORATORY VALUES: PT/ptt > 1.5 X ULN Total serum testosterone levels within normal limits for gender. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions will be excluded: 1. Acute systemic opportunistic infections within 30 days prior to entry. 2. Weight gain >= 3% as documented by self reporting or clinical records during the preceding 4 weeks. 3. History of hypersensitivity reaction to megestrol acetate or testosterone enanthate. 4. History of cardiomyopathy or congestive heart failure. Female patients: 5. History of invasive cervical cancer. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Positive pregnancy test. Pregnant. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. PRIOR MEDICATION: Excluded: 1. No testosterone treatment within the previous 8 weeks. Excluded within 30 days prior to entry: 2. Ketoconazole. 3. Initiation or change in antiretroviral therapy. 4. Interleukins. 5. Interferon, anabolic, hormonal or experimental therapies designed to improve appetite or weight gain (e.g. thalidomide, dronabinol, megestrol acetate, cyprohepthdine, anabolic steroids, systemic glucocorticoids, pentoxifylline, or growth hormone). CONCURRENT MEDICATION: Excluded: 1. Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's sarcoma (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be excluded). 2. Total or peripheral parenteral nutrition (oral supplements are not excluded). 3. Anticoagulant therapy. 4. Any drug that is designed to affect appetite or weight gain. 5. Any change of antiretroviral or any change in the dosage of antiretroviral/s that had not been started 30 days pre-entry. 6. Anabolic hormones. 7. Systemic glucocorticoids. 8. Cytokine inhibitors. 9. Oral contraceptives. 10. Cytokines. 11. Ketoconazole. 12. Any other medication that might interfere with the objectives of this study. CO-EXISTING CONDITIONS OR DISEASES: Patients with any of the following symptoms or conditions are excluded: 1. Diabetes mellitus. 2. Diarrhea defined as 4 or more liquid or watery stool per day while using antidiarrheal medication. 3. Tube feeding. 4. Impaired oral intake due to mucositis of any cause. 5. Grade 2 or greater intractable nausea and vomiting despite medication. 6. Cardiomyopathy or congestive heart failure. 7. Persistent palpable dominant breast mass at study entry that has not been worked up - males and females. Female patients: 8. Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions or cervial intraepithelial lesions 2 or worse. GENERIC DRUG NAME ----------------- Drug 1: Megestrol acetate. Appetite stimulant. Drug 2: Testosterone enanthate. Appetite stimulant. DRUG COMPANIES -------------- Drug 1: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Sharon Duncan (609) 897-2126. Drug 2: BioTechnology General Corporation 70 Wood Avenue, South Iselin, NJ 08830 Contact: Herb Henney (908) 632-8800. END POINT --------- Change from baseline of lean body mass at week 12. DISCONTINUE TREATMENT --------------------- Patients may be discontinued from the study for the following reasons: 1. Hypertension that is not responsive to medical therapy. 2. Any thrombotic phenomenon. 3. A Grade 3 (> 5-10 X ULN) liver toxicity for subjects entering the study with liver enzymes, <= 2.5 X ULN or if liver enzymes increase to 10-15 X ULN for subjects who enter study with liver enzymes of > 2.5 X ULN. 4. Unacceptable drug toxicity. 5. Patient or legal guardian refuses further treatment and/or follow up evaluations. 6. The investigator determines that further participation would be detrimental to the patient's health or well-being. 7. The patient fails to comply with the study requirements so as to cause harm to self or seriously interfere with the validity of the study results. 8. Patient requires treatment with medications that are disallowed while on this study. 9. Palpable dominant breast mass. 10. The patient becomes debilitated due to HIV progression such that the administration of the study treatment and/or protocol follow up is no longer feasible. Female patients: 11. Pregnancy. 12. Invasive cervical cancer. 13. Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions. PARTICIPATING UNITS ------------------- 0000001381: San Francisco General Hospital 995 Potrero Avenue / Building 80 / Ward 84 San Francisco, CA 94110-2859 Contact: David Gary (415) 476-9296 X 354 OPEN 961226 ACTU: 0801. 0000002265: University of Colorado Health Sciences Center 4200 East 9th Avenue / Colorado ACTU / Campus Box B-163 Denver, CO 80262 Contact: M Graham Ray (303) 372-5535 OPEN 961223 ACTU: 6101. 0000002175: Howard University 2112 Georgia Avenue NW Washington, DC 20059 Contact: Dr Yvette Butler (202) 806-4700 OPEN 970109 ACTU: 5301. 0000001365: Northwestern University Medical School 303 East Superior Street / Passavant Pavilion / Room 823 Chicago, IL 60611 Contact: Baiba L Berzins (312) 908-4655 Contact: (312) 908-9636 OPEN 961223 ACTU: 2701. 0000003592: Wishard Hospital / Indiana University Hospital 1001 West 10th Street / OPW 430 Indianapolis, IN 46202 Contact: Beth Zwickl (317) 274-8456 Contact: Heather Nixon (317) 274-8456 OPEN 970116 ACTU: 2603. 0000001361: Indiana University Hospital 550 North University Boulevard / Room 5550 Indianapolis, IN 46202-5250 Contact: Beth Zwickl (317) 274-8456 OPEN 970115 ACTU: 2601. 0000001346: Charity Hospital / Tulane University Medical School 1532 Tulane Avenue / 5th floor / East 505 New Orleans, LA 70112 Contact: Russell Strada (504) 584-3605 Contact: (504) 584-1692 OPEN 961226 ACTU: 1702. 0000001360: Tulane University School of Medicine 1430 Tulane Avenue / SL-87 New Orleans, LA 70112-2699 Contact: Russell Strada (504) 584-3605 Contact: (504) 584-1692 OPEN 970106 ACTU: 1701. 0000001350: New England Deaconess Hospital One Autumn Street / Kennedy Building / 6th Floor Boston, MA 02215 Contact: Helen Fitch (617) 632-0785 OPEN 961230 ACTU: 0103. 0000001335: Washington University School of Medicine 4511 Forest Park / Suite 304 St Louis, MO 63108 Contact: Michael Klebert (314) 454-0058 OPEN 961230 ACTU: 2101. 0000001336: St Louis Regional Hospital / St Louis Regional Med Center 5535 Del Mar / West Annex / 6th Floor St Louis, MO 63112 Contact: Michael Conklin (314) 879-6412 OPEN 961230 ACTU: 2102. 0000001340: Duke University Medical Center Hospital South / Room 0207 / PO Box 3284 Durham, NC 27710 Contact: Robert Dodge (919) 681-6060 Contact: (919) 684-8111 X 1564 OPEN 961224 ACTU: 1601. 0000001317: Beth Israel Medical Center First Avenue at 16th Street New York, NY 10003 Contact: Ann Marshak (212) 420-4432 OPEN 961224 ACTU: 1802. Date: Thu, 30 Jan 97 14:44:48 EST From: "David Radune" Subject: New Information from ACTIS: Protocols FDA260a & b NEW INFORMATION FROM ACTIS January 30, 1997 The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of a recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ******************************************************************************* PROTOCOL NUMBER: FDA 260A. TITLE: An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Documented HIV infection. 2. CD4 cell count of 200 - 700 cells/mm3 measured at screening. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. CD4 cell count of 200 - 700 cells/mm3. [Refer to Laboratory values for additional requirements.] AGE: 16 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Not breast-feeding. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: 200 - 700 cells/mm3. ( 200 - 300 - 400 - 500 - 600 - 700) OTHER LABORATORY VALUES: Qualifying plasma HIV RNA count of >= 10,000 copies/ml PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Breast-feeding. PRIOR MEDICATION: Excluded: Patients with any history of antiretroviral therapy treatment. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. GENERIC DRUG NAME ----------------- Drug 1: Zidovudine. Antiretroviral. Drug 3: Stavudine. Antiretroviral. Drug 4: Lamivudine. Antiretroviral. Drug 5: Indinavir sulfate. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Retrovir. Drug 3: Zerit. Drug 4: Epivir. Drug 5: Crixivan. DRUG COMPANIES -------------- Drug 1: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 3: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 4: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 5: Merck Research Laboratories 126 East Lincoln Avenue Rahway, NJ 07065 Contact: Unspecified (800) 379-1332 Contact: Dr Paul Deutsch (908) 594-5833. END POINT --------- Tolerance, efficacy and safety. PARTICIPATING UNITS ------------------- 0000003712: University of Alabama at Birmingham / Div of Infect Dis 908 20th Street South / 230 Byrd Building Birmingham, AL 35294 Contact: Betty McCulloch (205) 934-8087 OPEN 970115. 0000003709: HIV Clinical Research Center 300 SE 17th Street / 1st floor Ft Lauderdale, FL 33316 Contact: Tim Palmer-Pattison (954) 457-3006 OPEN 970115. 0000002995: Infectious Disease Research Institute Incorporated 4728 North Habana Avenue / Suite 303 Tampa, FL 33614 Contact: Kalliope Halkias (813) 875-4374 OPEN 970115. 0000003708: Advance Clinical Research 3193 Howell Mill Road / Suite 306 Atlanta, GA 30327 Contact: Kimberly Cole (404) 350-5690 OPEN 970115. 0000003704: Louisianna State Univ / Med Cntr of LA / Outpatient Clinic 136 South Roman Street New Orleans, LA 70112 Contact: Marsha Bennett (504) 568-7041 OPEN 970115. 0000003706: Boston University Medical Center Hospital / Evans - 556 66 East Newton Street Boston, MA 02118 Contact: Nancy Reinhalter (617) 636-7520 OPEN 970115. 0000003705: Community Research Initiative of New England 320 Washington Street / 3rd Floor Brookline, MA 02146 Contact: Virginia Andradas (617) 566-4004 OPEN 970115. 0000002219: Washington University School of Medicine 4511 Forest Park / Suite 304 St Louis, MO 63108 Contact: Michael Klebert (314) 454-0058 OPEN 970115. 0000002694: Hospital Regional de Ponce (Area Vieja) Carr 14 / Machuelo Ponce, PR 00731 Contact: Carmen Cabrera (809) 259-4731 OPEN 970115. 0000003711: San Juan AIDS Program 1306 Femandez Juncos Avenue / Stop 19 Santurce, PR 00906 Contact: Marty Mignucci (787) 756-8903 OPEN 970115. 0000003713: Blackstock Family Health Center 4614 North IH-35 / CTMF HIV Study Group Austin, TX 76751 Contact: Caryll Pithey (512) 458-9176 OPEN 970115. ***************************************************************** PROTOCOL NUMBER: FDA 260B. TITLE: An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects with CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 copies/ml. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Documented HIV infection. 2. CD4 cell count of 200 - 700 cells/mm3 measured at screening. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. CD4 cell count of 200 - 700 cells/mm3. [Refer to Laboratory values for additional requirements.] AGE: 16 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: 200 - 700 cells/mm3. ( 200 - 300 - 400 - 500 - 600 - 700) OTHER LABORATORY VALUES: Qualifying plasma HIV RNA count of >= 10,000 copies/ml PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. PRIOR MEDICATION: Excluded: Patients with any history of antiretroviral therapy treatment. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. GENERIC DRUG NAME ----------------- Drug 1: Zidovudine. Antiretroviral. Drug 2: Didanosine. Antiretroviral. Drug 3: Stavudine. Antiretroviral. Drug 4: Lamivudine. Antiretroviral. Drug 5: Indinavir sulfate. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Retrovir. Drug 2: Videx. Drug 3: Zerit. Drug 4: Epivir. Drug 5: Crixivan. DRUG COMPANIES -------------- Drug 1: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 2: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 3: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 4: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Information (800) 662-7999. Drug 5: Merck Research Laboratories 126 East Lincoln Avenue Rahway, NJ 07065 Contact: Unspecified (800) 379-1332 Contact: Dr Paul Deutsch (908) 594-5833. END POINT --------- Safety, tolerance and efficacy. PARTICIPATING UNITS ------------------- 0000003714: Harbor UCLA Medical Center / Division of Immunology / N-24 1000 West Carson Street Torrance, CA 90509 Contact: Crystal Lane (310) 222-2467 OPEN 970115. 0000003716: East Bay AIDS Clinic 3031 Telegraph Avenue / Suite 235 Berkeley, CA 94705 Contact: Nancy Orcutt (510) 204-1870 OPEN 970115. 0000003721: George Washington Medical Center / Clinical Trials Unit 2300 I Street NW / Room 202 Washignton, DC 20037 Contact: Jane Courtless (202) 994-0003 OPEN 970115. 0000003724: Anderson Clinical Research 2311 M Street / NW / Suite 401 Washington, DC 20037 Contact: Unspecified (202) 223-9130 OPEN 970115. 0000003723: Chicago Center for Clinical Research 515 North State Street / Suite 2700 Chicago, IL 60610 Contact: Bridget Murlock (312) 494-2230 OPEN 970115. 0000003720: Northwestern University 303 Superior Street / Room 823 / Passavant Pavillion Chicago, IL 60611 Contact: Nancy Priller (312) 908-0949 OPEN 970115. 0000003717: University of North Carolina / Infectious Disease Division 547 Burnett-Womack / CB #7030 Chapel Hill, NC 27599 Contact: Barbara Longmire (919) 966-2536 OPEN 970115. 0000003719: The Nalle Clinic / Clinical Research Department 1918 Randolph Road Charlotte, NC 28207 Contact: Jan Caldwell (704) 342-8318 OPEN 970115. 0000003725: University of Nebraska 600 South 42nd Street Omaha, NE 68195 Contact: Jane Hamer (402) 559-8650 OPEN 970115. 0000003718: University of Pennsylvania / Infectious Diseases Division 536 Johnson Pavilion Philadelphia, PA 19104 Contact: Debora Dunbar (215) 562-2473 OPEN 970115. 0000002694: Hospital Regional de Ponce (Area Vieja) Carr 14 / Machuelo Ponce, PR 00731 Contact: Carmen Cabrera (809) 259-4731 OPEN 970115. 0000003715: Southwest Infectious Disease Association / PA 8226 Douglas Avenue / Suite 311 Dallas, TX 75225 Contact: Larry Stone (214) 890-7943 OPEN 970115. 0000003722: Univ of Texas Southwestern Medical Cntr / Dept of Inter Med 5323 Harry Hines Boulevard / KI - 900 Dallas, TX 75235 Contact: Claudia Quittner (214) 648-7653 OPEN 970115. Date: Thu, 30 Jan 97 14:44:52 EST From: "David Radune" Subject: New Information from ACTIS: Protocols FDA259a - d NEW INFORMATION FROM ACTIS January 30, 1997 The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of a recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ******************************************************************************* PROTOCOL NUMBER: FDA 259A. TITLE: A Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Cytomegalovirus (CMV) Retinitis in AIDS Patients who are Receiving Standard Induction and Maintenance Therapy for this Infection PHASE: Phase II. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV infection. 2. Newly diagnosed, or with first progression of CMV retinitis. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. Newly diagnosed or first progression of CMV retinitis. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Not specified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. PRIOR MEDICATION: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitor ather than saquinavir. GENERIC DRUG NAME ----------------- Drug 1: Nelfinavir. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Viracept. DRUG COMPANIES -------------- Drug 1: Agouron Pharmaceuticals Incorporated 10350 North Torrey Pines Road / Suite 100 La Jolla, CA 92037 Contact: Unspecified (619) 622-3000. PARTICIPATING UNITS ------------------- 0000003700: University of Southern California / LA County USC Med Cntr 2020 Zonal Avenue Los Angeles, CA 90033 Contact: Analyn Howells (212) 343-8278 OPEN 961101. 0000003695: Harbor UCLA Medical Center 1124 West Carson Street / Building N-24 Torrance, CA 90502 Contact: Crystal Lane (301) 222-3848 OPEN 961101. 0000003699: University of California / San Diego Treatment Center 2760 5th Avenue / Suite 300 San Diego, CA 92103 Contact: Cathy McCormick (619) 543-8080 OPEN 961101. 0000003698: University of California / UCI Medical Center 101 City Drive South / Building 53 / Route 81 Orange, CA 92868 Contact: Bobi Keenan (714) 456-7612 OPEN 961101. 0000003696: George Washington University 2300 I Street / NW Washington, DC 20037 Contact: Suzanne Schuck (202) 994-2417 OPEN 961101. 0000001842: Northwestern University / SOCA 645 North Michigan / Suite 440 Chicago, IL 60611 Contact: Annie Munana (312) 908-8040 X 9700 OPEN 961101. 0000003697: Baylor University 2015 Thomas Street Houston, TX 77009 Contact: Barbara Sepcie (713) 793-4020 OPEN 961101. 0000003694: University of Texas Medical Branch 200 University Boulevard / Suite 518 Galveston, TX 77555 Contact: Cheryl Coufal (409) 747-0241 OPEN 961101. ***************************************************************** PROTOCOL NUMBER: FDA 259B. TITLE: Viracept Expanded Access Program DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV infection. 2. CD4 T cell count of <= 50 cells/mm3 within 90 previous days of study entry. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 T cell count <= 50 cells/mm3. 3. Failed, been intolerant of or had a contraindication to all three commercially available protease inhibitors (saquinavir, indinavir and ritonavir). [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. PRIOR MEDICATION: Required: 1. Indinavir. 2. Saquinavir. 3. Ritonavir. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: <= 50 cells/mm3. (0 - 50) PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. PRIOR MEDICATION: Excluded: Prior therapy with Viracept. GENERIC DRUG NAME ----------------- Drug 1: Nelfinavir. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Viracept. DRUG COMPANIES -------------- Drug 1: Agouron Pharmaceuticals Incorporated 10350 North Torrey Pines Road / Suite 100 La Jolla, CA 92037 Contact: Unspecified (619) 622-3000. PARTICIPATING UNITS ------------------- 0000003726: Agouron Pharmaceuticals Incorporated 10350 North Torry Pines Road / Suite 100 La Jolla, CA 92037 Contact: Unspecified (800) 621-7111 OPEN 961001. ***************************************************************** PROTOCOL NUMBER: FDA 259C. TITLE: A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium avium Complex Disease (MAC) in AIDS Patients who are Receiving Standard Acute Treatment for This Opportunistic Infection PHASE: Phase II. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV infection 2. New diagnosis of MAC bacteremia and < 7 days of therapy. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection 2. New diagnosis of MAC bacteremia and < 7 days of therapy. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. PRIOR MEDICATION: Allowed: Patients no more than 7 days of therapy for MAC disease. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Not specified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. PRIOR MEDICATION: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir. GENERIC DRUG NAME ----------------- Drug 1: Nelfinavir. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Viracept. DRUG COMPANIES -------------- Drug 1: Agouron Pharmaceuticals Incorporated 10350 North Torrey Pines Road / Suite 100 La Jolla, CA 92037 Contact: Unspecified (619) 622-3000. PARTICIPATING UNITS ------------------- 0000003695: Harbor UCLA Medical Center 1124 West Carson Street / Building N-24 Torrance, CA 90502 Contact: Crystal Lane (301) 222-3848 OPEN 961201. 0000003699: University of California / San Diego Treatment Center 2760 5th Avenue / Suite 300 San Diego, CA 92103 Contact: Cathy McCormick (619) 543-8080 OPEN 961201. 0000003701: Rush Presbyterian - Saint Luke's Medical Center 600 South Paulina Street / Suite 143 Chicago, IL 60612 Contact: Study Coordinator (312) 942-5865 OPEN 961201. 0000003703: Boston VA Medical Center / 151 150 South Huntington Avenue Boston, MA 02730 Contact: Joel Maslow (617) 232-9500 X 5576 OPEN 961201. 0000003697: Baylor University 2015 Thomas Street Houston, TX 77009 Contact: Barbara Sepcie (713) 793-4020 OPEN 961201. ***************************************************************** PROTOCOL NUMBER: FDA 259D. TITLE: A Phase II, Randomized, Placebo Controlled Study of the Safety and Efficacy of Viracept in Combination with Antiretroviral Therapy in HIV Positive Women with <= 1 Month of Prior Treatment with d4T and/or 3TC PHASE: Phase II. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV infection. 2. CD4 T cell count <= 400 cells/mm3. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 T cell count <= 400 cells/mm3. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: F. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: <= 400 cells/mm3. ( 0 - 100 - 200 - 300 - 400) PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 12 Years. SEX: M. PRIOR MEDICATION: Excluded: 1. Prior therapy or less than 1 month of therapy with d4T and/or 3TC. 2. Prior protease inhibitor therapy. GENERIC DRUG NAME ----------------- Drug 1: Nelfinavir. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Viracept. DRUG COMPANIES -------------- Drug 1: Agouron Pharmaceuticals Incorporated 10350 North Torrey Pines Road / Suite 100 La Jolla, CA 92037 Contact: Unspecified (619) 622-3000. PARTICIPATING UNITS ------------------- 0000002171: University of Alabama at Birmingham 908 20th Street South Birmingham, AL 35294-2041 Contact: Betty McCulloch (205) 975-7925 OPEN 961201 ACTU: 5801. 0000003702: University of Southern California / LA County USC Med Cntr 2020 Zonal Avenue / Room 309 Los Angeles, CA 90033 Contact: Luis Mendez (213) 343-8250 OPEN 961201. 0000003710: HIV Outpatient Clinics / LA State University Medical Center 136 South Roman Street / 3rd Floor New Orleans, LA 70112 Contact: Study Coordinator (504) 568-7049 OPEN 961201. 0000003697: Baylor University 2015 Thomas Street Houston, TX 77009 Contact: Barbara Sepcie (713) 793-4020 OPEN 961201.