by aspensys.aspensys.com with SMTP; 6 Mar 1997 22:24:03 -0000 Date: Thu, 06 Mar 97 16:54:45 EST From: "David Radune" Subject: New Information from ACTIS 03/06/97: ACTG 331 & ACTG 340 March 6, 1997 NEW INFORMATION FROM ACTIS 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 331. TITLE: The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Evidence of maternal HIV infection documented by an EIA with appropriate confirmatory test, positive p24 antigen, or positive viral culture (blood or CSF). 2. Require ZDV therapy in opinion of primary physician. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Evidence of maternal HIV infection. 2. Require ZDV therapy in opinion of primary physician. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 05 Days. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- PLATELET COUNT: > 50,000 platelets/mm3. CD4 (T4 CELL) COUNT: Unspecified cells/mm3. CD4/CD8 RATIO: Unspecified. BILIRUBIN: <= 3 mg/dl. OTHER LABORATORY VALUES: Neutrophil > 750 cells/mm3 PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] PRIOR TREATMENT: Excluded: 1. Exchange transfusion within 24 hours of study enrollment. 2. Granulocyte transfusion within 24 hours of study enrollment. CO-EXISTING CONDITIONS OR DISEASES: Patients having any of the following symptoms or conditions are excluded: 1. Life threatening or severe illness and not expected to survive 6 weeks. 2. Hypotension and/or poor perfusion requiring treatment with volume expansion and/or vasopressors. 3. Urine output less than 0.5 ml/kg/hr within 24 hours of study enrollment. NOTE: If exclusion criterion is present, but resolves within the first 5 days of life, patient is eligible to enroll. GENERIC DRUG NAME ----------------- Drug 1: Zidovudine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Retrovir. DRUG COMPANIES -------------- Drug 1: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Dept of Consumer Affairs (800) 437-0992 X 7900. END POINT --------- Pharmacokinetics and tolerance. DISCONTINUE TREATMENT --------------------- Patients may be discontinued for any of the following reasons: 1. Patient or legal guardian wishes to withdraw, refuses further treatment and/or follow up evaluations. 2. The investigator determines that further participation would be detrimental to the subject's health or well-being. 3. The parent or legal guardian fails to comply with the study requirements so as to cause harm to the subject or seriously interfere with the validity of the study results. 4. Patient misses > 14 consecutive days of the drug regimen because of noncompliance. 5. Unacceptable drug toxicity. PARTICIPATING UNITS ------------------- 0000001402: UCLA Medical Center / Pediatric 10833 Le Conte Avenue / 22-404 MDCC Los Angeles, CA 90095-1752 Contact: Leslie Spring (310) 206-6369 OPEN 970116 ACTU: 3601. 0000001378: UCSD Medical Center / Pediatrics 200 West Arbor Drive San Diego, CA 92103-8765 Contact: Candace McIvor (619) 534-7170 OPEN 970121 ACTU: 4601. 0000003235: University of Florida Health Science Center / Pediatrics 653-1 West 8th Street Jacksonville, FL 32209 Contact: Michelle Eagle (904) 549-3051 OPEN 970116 ACTU: 5051. 0000001368: University of Miami School of Medicine / Pediatrics 1800 Northwest 10th Avenue / D-91 Miami, FL 33136 Contact: Brenda Haliburton-Jones (305) 548-4445 OPEN 970124 ACTU: 4201. 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. 0000001353: Boston City Hospital / Pediatrics 774 Albany Street / Finland Lab / Room 301 Boston, MA 02118 Contact: Anne Marie Regan (617) 534-5813 OPEN 970116 ACTU: 2903. 0000001341: Duke University Medical Center PO Box 3499 Durham, NC 27710 Contact: John Swetnam (919) 684-6335 OPEN 970206 ACTU: 4701. 0000001276: Harlem Hospital Center 506 Lenox Avenue / Room 16-119 New York, NY 10037 Contact: Delia Calo (212) 939-4045 Contact: (212) 939-4043 OPEN 970116 ACTU: 5006. 0000001280: Westchester Hospital Munger Pavilion / Room 108 Valhalla, NY 10595 Contact: Liz Ahern (914) 285-7898 Contact: (914) 993-4643 OPEN 970121 ACTU: 5005. ***************************************************************** PROTOCOL NUMBER: NIAID ACTG 340. TITLE: Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations IN HIV-1-Infected Individuals DISEASE STATUS: Patients must have the following conditions and symptoms: 1. HIV infection as documented by any licensed ELISA test kit and confirmed by either Western Blot, HIV antigen, HIV culture, or a second antibody test other than ELISA. 2. CD4 lymphocyte count of > 300 cells/mm3 within 60 days prior to study entry as measured in a certified ACTG laboratory. 3. One plasma HIV-1 RNA level between >= 20,000 and < 120,000 copies/ml within 60 days of study entry for patients not on antiretroviral therapy or within 30 days of study entry for patients on antiretroviral therapy. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. CD4 lymphocyte count of > 300 cells/mm3. 3. One plasma HIV-1 RNA level between >= 20,000 and < 120,000 copies/ml. [Refer to Laboratory values for additional requirements.] AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. Negative pregnancy test. Abstinence or effective method of birth control / contraception including oral contraceptives during the study. PRIOR MEDICATION: Allowed: Stable antiretroviral therapy. CONCURRENT MEDICATION: Allowed: Antiretroviral therapy, provided the patient has been on the same dose and drugs for 60 days prior to study entry. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 9 g/dl. for men and >= 8.5 g/dl for women. CD4 (T4 CELL) COUNT: > 300 cells/mm3. (300 - 400 - 500 - 600 - 700 - 800 - PLUS) SGOT (AST): <= 5 X ULN. (ULN = Upper limit of normal) SGPT (ALT): <= 5 X ULN. CREATININE: <= 1.5 X ULN. KARNOFSKY: >= 80. OTHER LABORATORY VALUES: Absolute neutrophil count >= 1000 cells/mm3. Amylase <= 1.5 X ULN; if > 1.5 ULN, a lipase <= 1.5 X ULN is sufficient for inclusion. Plasma HIV-1 RNA level between >= 20000 and < 120000 copies/ml. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions are excluded: 1. History of a AIDS defining opportunistic infection, including Kaposi's sarcoma (except limited cutaneous diseases [< 5 lesions]). 2. History of acute or chronic pancreatitis. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. Positive pregnancy test. No abstinence or no agreement to use effective method of birth control / contraception during the study. CONCURRENT TREATMENT: Excluded: 1. Radiation therapy. 2. Transfusion dependent patients. PRIOR MEDICATION: Excluded: 1. Prior treatment with 3TC. Excluded within 30 days of study entry: 2. Treatment with immune modulators. 3. Acute or chronic therapy for recognized infections (eg, influenza, HSV, VZV). Excluded within 1 year of study entry: 4. Treatment with an influenza and/or pneumonia vaccine. CONCURRENT MEDICATION: Excluded: 1. Systemic chemotherapy. 2. Steroids. 3. Corticosteroids. 4. Vaccinations. 5. Any new antiretroviral agents that the patient was not taking at the time of study entry and not prescribed by the study. 6. Colony stimulating factors including G-CSF or rEPO. 7. Immune modulators/immune based therapies. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Presence of a AIDS defining opportunistic infection, including Kaposi's sarcoma. 2. Allergy to influenza or pneumococcal vaccine or their components; to egg or egg products. 3. Unexplained temperature >= 38.5 degrees C for 7 consecutive days within the 30 days prior to study entry. 4. Concurrent participation in other experimental therapies. GENERIC DRUG NAME ----------------- Drug 1: Pneumococcal vaccine polyvalent ( 23-valent ). Vaccine. Drug 2: Influenza virus vaccine. Vaccine. Drug 3: Lamivudine. Antiretroviral. DRUG TRADE NAME --------------- Drug 2: Fluogen. Drug 3: Epivir. DRUG COMPANIES -------------- Drug 1: Lederle - Praxis Biologicals 211 Bailey Road West Henrietta, NY 14586-9728 Contact: Dr Frank Malinoski (716) 272-7000. Drug 2: Warner - Lambert Parke - Davis 201 Tabor Road Morris Plains, NJ 07950 Contact: Unspecified (800) 537-9978. Drug 3: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Dept. of Consumer Affairs (800) 437-0992 X 7900. END POINT --------- Change in proportion of plasma virus with M184I/V mutation at Day 28 as compared to Day 14 in vaccinated versus unvaccinated group. DISCONTINUE TREATMENT --------------------- Patients may be discontinued from the study for any of the following reasons: 1. The patient or legal guardian refuses further treatment and/or follow up evaluations. 2. The investigator determines that further participation would be detrimental to the subject's health or well-being. 3. 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. 4. The patient requires treatment with medications which are disallowed while on this study. 5. Unacceptable drug toxicity. 6. Pregnancy. PARTICIPATING UNITS ------------------- 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 970109 ACTU: 0701. 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 970109 ACTU: 6101. *****************************************************************