Date: Fri, 20 Sep 1996 16:05:20 -0400 From: "Flynn Mclean" Subject: New Information from ACTIS 09/19/96 (1 of 2) September 19, 1996 1 of 2 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. Descriptions of four clinical trials and two drugs added to the ACTIS database are 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 229D. TITLE: A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs. PHASE: Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infection. 2. Antiretroviral naive (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs. 3. No more than 2 weeks of prior treatment with a protease inhibitor. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. Antiretroviral naive (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs. 3. No more than 2 weeks of prior treatment with a protease inhibitor. AGE: 13 Years - 99 Years. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 12 Years. PRIOR MEDICATION: Excluded: 1. More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen. 2. More than 2 weeks of any protease inhibitor. CONCURRENT MEDICATION: Excluded: Other protease inhibitors. GENERIC DRUG NAME ----------------- Drug 1: Saquinavir mesylate. Protease inhibitor. Drug 2: Zidovudine. Antiretroviral. Drug 3: Zalcitabine. Antiretroviral. Drug 4: Didanosine. Antiretroviral. Drug 5: Stavudine. Antiretroviral. Drug 6: Lamivudine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Invirase. Drug 2: Retrovir. Drug 3: HIVID. Drug 4: Videx. Drug 5: Zerit. Drug 6: Epivir. DRUG COMPANIES -------------- Drug 1: Hoffmann - La Roche Incorporated 340 Kingsland Street Nutley, NJ 07110-1199 Contact: Professional Services (800) 526-6367. Drug 2: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Department of Consumer Affairs (800) 437-0992 X 7900. Drug 3: Hoffmann - La Roche Incorporated 340 Kingsland Street Nutley, NJ 07110-1199 Contact: Professional Services (800) 526-6367. Drug 4: Bristol - Myers Squibb Company 2400 West Lloyd Expressway Evansville, IN 47721-0001 Contact: Information (800) 662-7999. Drug 5: Bristol - Myers Squibb Company 2400 West Lloyd Expressway Evansville, IN 47721-0001 Contact: Information (800) 662-7999. Drug 6: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Department of Consumer Affairs (800) 437-0992 X 7900. END POINT --------- Drug efficacy, toxicity. PARTICIPATING UNITS ------------------- 0000003604: UCSD Treatment Center 2760 Fifth Avenue / 3rd Floor San Diego, CA 92103-6329 Contact: Ron Snyder (619) 543-8080 OPEN 960916. 0000003605: Mount Zion Hospital of UCSF 2300 Sutter Street / Suite 202 San Francisco, CA 94115 Contact: John Sayre (415) 885-7737 OPEN 960916. 0000003462: San Francisco Veterans Administration Medical Center 4150 Clement Street San Francisco, CA 94121 Contact: Sandy Charles (415) 221-4810 X 3763 OPEN 960916. 0000003609: AIDS Research Center Dept of Veterans Affairs / 3801 Miranda Avenue / III-ID Palo Alto, CA 94304 Contact: Mark Mistal (415) 493-5000 X 64926 OPEN 960916. 0000001499: University of Colorado Health Sciences Center 4200 East 9th Avenue / Box B-163 Denver, CO 80262 Contact: M Graham Ray (303) 372-5535 OPEN 960918. 0000003607: New England Medical Center 750 Washington Street / NEMCH67 Boston, MA 02111 Contact: Charlene Gaca (617) 636-8186 OPEN 960916. 0000003594: Harvard University / Massachusetts General Hospital 55 Fruit Street / Gray 5 Boston, MA 02114 Contact: Ellen Godfrey McCarthy (617) 726-5598 OPEN 960916. 0000003608: Beth Israel Medical Center First Avenue at 16th Street New York, NY 10003 Contact: Gwen Constantini (212) 420-4519 OPEN 961021. 0000003606: University of Texas Medical Branch Route 0835 / 301 University Boulevard Galveston, TX 77555-0835 Contact: Phyliss Galatas (409) 747-0241 OPEN 960916. ************************************************************************* PROTOCOL NUMBER: FDA 232C. TITLE: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infection. 2. HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma by branched DNA analysis within the past 2 weeks. 3. CD4 count >= 200 cells/mm3 within the past month. 4. No new AIDS-defining event within the past 2 months. 5. Tolerated antiretroviral therapy for the past 2 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma. 2. CD4 count >= 200 cells/mm3. 3. No new AIDS-defining event within the past 2 months. 4. Life expectancy at least 1 year. 5. Consent of parent or guardian if less than 18 years old. 6. Tolerated antiretroviral therapy for the past 2 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month. AGE: 13 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test within 14 days of study entry. Not breast-feeding. Abstinence or effective method of birth control / contraception including oral contraceptives during the study. PRIOR MEDICATION: Required: Antiretroviral therapy for at least the past 2 months. CONCURRENT MEDICATION: Required: Antiretroviral regimen other than study drug. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 8 g/dl. (without hematologic growth factors). PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: >= 200 cells/mm3. ( 200 - 300 - 400 - 500 - 600 - 700 - 800 - plus ). SGOT (AST): <= 3 x ULN. (ULN = upper limit of normal). SGPT (ALT): <= 3 x ULN. CREATININE: <= 1.5 x ULN. KARNOFSKY: >= 80. OTHER LABORATORY VALUES: Absolute neutrophils >= 750 cells/mm3. Serum amylase <= 1.5 x ULN ( if serum amylase > 1.5 x ULN, then pancreatic amylase or lipase < 1.5 x ULN may be substituted). PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 12 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test within 14 days of study entry. Breast-feeding. No abstinence or no agreement to use effective method of birth control / contraception during the study. RISK BEHAVIOR: Current alcohol or substance abuse that would interfere with compliance. PRIOR MEDICATION: Excluded: 1. Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks. 2. Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month. 3. Systemic therapy for KS within the past month. CONCURRENT MEDICATION: Excluded: 1. Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons. 2. Isoniazid. 3. Rifampin. 4. Investigational agents (unless approved by sponsor). 5. Systemic chemotherapeutic agents. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy. 2. Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication. 3. Malignancy other than Kaposi's sarcoma or basal cell carcinoma. GENERIC DRUG NAME ----------------- Drug 1: Adefovir dipivoxil. Antiretroviral. DRUG COMPANIES -------------- Drug 1: Gilead Sciences Incorporated 353 Lakeside Drive Foster City, CA 94404 Contact: Dr Jay Toole (415) 573-4751. END POINT --------- Drug efficacy, toxicity. PARTICIPATING UNITS ------------------- 0000003593: University of Alabama at Birmingham 908 20th Street South Birmingham, AL 35294-2041 Contact: Betty McCulloch (205) 975-7925 OPEN 960808. 0000002310: Harbor - UCLA Medical Center 1124 West Carson Street / Lab E2 Torrance, CA 90502 Contact: Sally Krueger (310) 533-3848 OPEN 960808. 0000003567: Kraus Medical Partners 5901 West Olympic Blvd / Suite 310 Los Angeles, CA 90509 Contact: Uni Kim (213) 930-2324 OPEN 960808. 0000003571: Pacific Oaks Research 4940 Van Nuys Boulevard / 2nd Floor Sherman Oaks, CA 91403 Contact: Sindy Kim (818) 906-6279 OPEN 960808. 0000003568: San Francisco General Hospital 995 Potrero Avenue / Building 80 / Ward 84 San Francisco, CA 94115 Contact: Anna Smith (415) 476-4082 X 84098 OPEN 960808. 0000003572: San Mateo County Medical Center / San Mateo County AIDS Prog 3700 Edison Street San Mateo, CA 94403 Contact: Brian Camp (415) 364-6563 OPEN 960808. 0000003151: East Bay AIDS Center 3031 Telegraph Avenue / Suite 235 Berkeley, CA 94705 Contact: Nancy Orcutt (510) 204-1291 OPEN 960808. 0000002575: Santa Clara Valley Medical Center 751 South Bascom Avenue San Jose, CA 95128-2699 Contact: Carol Kane (408) 885-4316 Contact: Dr Carol Kemper (assoc dir) (408) 885-4300 OPEN 960808. 0000003509: Georgetown University Medical Center 3800 Reservoir Road NW / Kober - Cogan Building / Suite 110 Washington, DC 20007 Contact: Irene Scanlon RN (202) 687-1079 Contact: (202) 687-6845 OPEN 960808. 0000003570: Institute for Clinical Research 50 Irving Street NW 151-B / VA Medical Center Washington, DC 20422 Contact: Peg Lankford (202) 745-8000 X 5007 Contact: Donna Mills OPEN 960808. 0000002252: University of South Florida 5471 4th Street South St Petersburg, FL 33705 Contact: Pat Seeley (813) 974-3163 OPEN 960808. 0000003603: AIDS Research Consortium of Atlanta 131 Ponce de Leon Avenue / Suite 130 Atlanta, GA 30308 Contact: Harriotte Bohn (404) 876-2317 OPEN 960912. 0000003577: Chicago Center / Clinical Research 515 North State Street / Suite 2700 Chicago, IL 60610 Contact: Julie Frowick (312) 494-2206 OPEN 960808. 0000002777: Northwestern University 303 East Superior Street / Passavant Pavilion / Room 828 Chicago, IL 60611 Contact: Pam Donath (312) 908-0949 OPEN 960808. 0000003575: Tulane University / Tulane/LSU Clinical Trials Unit 1430 Tulane Avenue New Orleans, LA 70122 Contact: Dawn Morgado (504) 587-7316 OPEN 960808. 0000003594: Harvard University / Massachusetts General Hospital 55 Fruit Street / Gray 5 Boston, MA 02114 Contact: Ellen Godfrey McCarthy (617) 726-5598 OPEN 960808. 0000003574: Wayne State University / University Health Center Pod 6F 4201 Saint Antoine Detroit, MI 48201 Contact: Helen Dries (313) 993-0926 OPEN 960808. 0000002129: Carolinas Medical Center 1000 Blythe Boulevard Charlotte, NC 28204 Contact: Dr James Horton (704) 355-5292 X 3165 Contact: Joan Connell (704) 355-5292 OPEN 960808. 0000003579: Saint Vincent's Medical Center 412 6th Avenue / Room 401 New York, NY 10011 Contact: M George (212) 228-8000 OPEN 960808. 0000003602: Saint Vincent's Medical Center 412 6th Avenue / Room 401 New York, NY 10011 Contact: Mary Katherine George (212) 228-8000 OPEN 960912. 0000003578: Albany Medical College / Clinical Pharmacy Studies Unit A-142 / 47 New Scotland Avenue Albany, NY 12208 Contact: Carol MacDonald (205) 975-6323 OPEN 960808. 0000003601: The Research and Education Group 2701 NW Vaughn / Suite 840 Portland, OR 97210-5311 Contact: Norma Martinez (503) 229-8428 OPEN 960912. 0000003580: Vanderbilt University Medical Center Medical Arts Building / 1211 Twenty-first Ave S / Ste 539 Nashville, TN 37212 Contact: D Haas (615) 936-1174 OPEN 960808. 0000003573: Dallas VA Medical Center 4500 Lancaster Road Dallas, TX 75216 Contact: Sherrie Norris (214) 648-3877 OPEN 960808. 0000003569: Houston Clinical Research Network 1200 Binz / Suite 120 Houston, TX 77004 Contact: Barbara Griffin (713) 520-2000 X 211 OPEN 960808. 0000003576: University of Texas 200 University Boulevard / Suite 518 Galveston, TX 77555-0835 Contact: Phyllis Galatas (409) 747-0241 OPEN 960808. 0000001480: University of Utah School of Medicine 50 North Medical Drive / Room 4B 322 Salt Lake City, UT 84132 Contact: Susan Bracken (801) 581-4878 OPEN 960808. 0000002960: University of Wisconsin 600 Highland Avenue / H-6/368 CSC Madison, WI 53792 Contact: Jeff Howells (608) 265-5729 OPEN 960808. ********************************************************************** Date: Fri, 20 Sep 1996 15:17:32 -0400 From: "Flynn Mclean" Subject: New Information from ACTIS 09/19/96 (2 of 2) New Information from ACTIS September 19, 1996 2 of 2 PROTOCOL NUMBER: FDA 256A. TITLE: A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain. PHASE: Phase II / Phase III. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Chronic pain related to HIV or cancer. 2. Unsatisfactory response to opioid therapy (intolerable side effects or inadequate pain relief). PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Chronic pain related to HIV or cancer. 2. Unsatisfactory response to prior opioid therapy. 3. Life expectancy > 3 months (or 1 month if an infusion pump is in place). AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Not breast-feeding. CONCURRENT MEDICATION: Allowed: Rescue analgesia. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: History of heart disease, heart failure, or asthma. AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Breast-feeding. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: Signs of sepsis or inadequately treated infection. GENERIC DRUG NAME ----------------- Drug 1: SNX-111. Calcium Channel Blocker. DRUG COMPANIES -------------- Drug 1: Neurex Corporation 3760 Haven Avenue Menlo Park, CA 94025 Contact: Unspecified (415) 853-1500. PARTICIPATING UNITS ------------------- 0000003563: Clinical Solutions 103 Carnegie Center / Suite 106 Princeton, NJ 08540 Contact: Unspecified (800) 577-8839 X 92 OPEN / USA accrual (Call for study sites) 960604. ******************************************************************* PROTOCOL NUMBER: FDA 257A. TITLE: Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients. (FDA DISCLAIMER: The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person.) PHASE: Phase I / Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV seropositive for at least 6 months. 2. CD4 >= 100 cells/mm3. 3. HIV RNA PCR (Amplicor) > 10000 copies/ml. 4. No significant active opportunistic infection or tumor at study entry. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV seropositive for at least 6 months. 2. CD4 >= 100 cells/mm3. 3. HIV RNA PCR (Amplicor) > 10000 copies/ml. 4. No significant active opportunistic infection or tumor at study entry. FDA DISCLAIMER: The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person. AGE: 18 Years - 65 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Postmenopausal or permanently sterile because of tubal ligation, hysterectomy, or oophorectomy. Not breast-feeding. PRIOR MEDICATION: Allowed: Prior antiretrovirals. CONCURRENT MEDICATION: Allowed: Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: > 10 g/dl. CD4 (T4 CELL) COUNT: >= 100 cells/mm3. ( 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 - plus ). BILIRUBIN: <= 3 x ULN mg/dl. (ULN = upper limit of normal). SGOT (AST): <= 3 x ULN. SGPT (ALT): <= 3 x ULN. CREATININE: <= 1.6 mg/dl. KARNOFSKY: > 70. OTHER LABORATORY VALUES: Neutrophils >= 500 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior condition are excluded: History of relevant drug hypersensitivity. AGE: 01 Days - 17 Years. 66 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Future reproduction. Breast-feeding. PRIOR MEDICATION: Excluded: Investigational drug within the past 4 weeks. CONCURRENT MEDICATION: Excluded: Any drug that may interact with SPC3 (e.g., suramin). CO-EXISTING CONDITIONS OR DISEASES: Patients with the following conditions are excluded: Inability to communicate with investigator or deemed likely to be noncompliant on study. GENERIC DRUG NAME ----------------- Drug 1: Synthetic Peptide Construction 3. Antiretroviral. DRUG COMPANIES -------------- Drug 1: Columbia Research Laboratories Incorporated 100 North Village Avenue / Suite 32 Rockville Centre, NY 11570 Contact: Dr Howard Levine (516) 766-2660. PARTICIPATING UNITS ------------------- 0000003590: Roger Williams Medical Center 825 Chalkstone Avenue Providence, RI 02908 Contact: Grace Acetta (401) 456-2532 OPEN 960822. ********************************************************************** DRUG RECORDS Accession Number: DRG-0250. Generic Name: SNX-111 (FDA 256A). Protocol Number(s): Open FDA 256A Alias/Trade Name: SNX 111 (MeSH). omega-Conopeptide MVIIA (MeSH). omega-Conotoxin MVIIA, Conus magus (MeSH). Chemical Abstract Name: omega-Conotoxin MVIIA (CHEMLINE). CAS Registry Number: 107452-89-1 (CHEMLINE). Drug Company(ies): Neurex Corporation 3760 Haven Avenue Menlo Park, CA 94025 Contact: Unspecified (415) 853-1500. Therapeutic Classification: Calcium Channel Blocker (CHEMLINE). Drug Description: Synthetic homologue of omega-conopeptide. (J Pharmacol Exp Ther 1995 Aug;274(2) p 666-72) Pharmacology: MODE OF ACTION: Relieves pain by interfering with the neurotransmission of pain impulses. Blocks neuronal N-type voltage-sensitive calcium channels. (FDA 256A; J Pharmacol Exp Ther 1995 Aug;274(2) p 666-72) Contraindications: Contraindicated in pregnant and nursing women. (FDA 256A) Mode of Delivery: Intrathecal. (FDA 256A) AIDS-Related Uses: Pain related to HIV. (FDA 256A) Other Uses: Pain related to cancer. (FDA 256A) Bibliographic References: 95363679. Xiao WH, Bennett GJ. Synthetic omega-conopeptides applied to the site of nerve injury suppress neuropathic pains in rats. J Pharmacol Exp Ther 1995 Aug;274(2):666-72. 95315196. Nadasdi L, Yamashiro D, Chung D, Tarczy-Hornoch K, Adriaenssens P, Ramachandran J. Structure-activity analysis of a Conus peptide blocker of N-type neuronal calcium channels. Biochemistry 1995 Jun 27;34(25):8076-81. 95126938. Kim JI, Takahashi M, Ohtake A, Wakamiya A, Sato K. Tyr13 is essential for the activity of omega-conotoxin MVIIA and GVIA, specific N-type calcium channel blockers. Biochem Biophys Res Commun 1995 Jan 17;206(2):449-54. 95067173. Hovda DA, Fu K, Badie, H, Samii A, Pinanong P, Becker DP. Administration of an omega-conopeptide one hour following traumatic brain injury reduces 45calcium accumulation. Acta Neurochir Suppl (Wien) 1994;60:521-3. *********************************************************************** Accession Number: DRG-0251. Generic Name: Synthetic Peptide Construction 3 (FDA 257A). Protocol Number(s): Open FDA 257A Alias/Trade Name: SPC3 (FDA 257A). SPC3 peptide (MeSH). Drug Company(ies): Columbia Research Laboratories Incorporated 100 North Village Avenue / Suite 32 Rockville Centre, NY 11570 Contact: Dr Howard Levine (516) 766-2660. Therapeutic Classification: Antiretroviral (FDA 257A). Drug Description: Synthetic multibranched peptide containing eight HIV-1 gp120 V3 loop GPGRAF motifs. (Biochemistry 1995 Jul 4;34(26) p 8294-8) Pharmacology: MODE OF ACTION: Data suggest that SPC3 prevents HIV-1 attachment to the surface of CD4- cells that express galactosylceramide, an alternative receptor for HIV-1 gp120. In CD4+ lymphocytes, SPC3 interferes with a post-binding step necessary for virus entry into the cell. (Proc Natl Acad Sci USA 1995 May 23;92(11) p 4867-71) Contraindications: Contraindicated in women of reproductive potential. (FDA 257A) Mode of Delivery: Intravenous. (FDA 257A) AIDS-Related Uses: HIV infection. (FDA 257A) Bibliographic References: MED/95281557. Yahi N, Fantini J, Baghdiguian S, Mabrouk K, Tamalet C, Rochat H, Van Rietschoten J, Sabatier JM. SPC3, a synthetic peptide derived from the V3 domain of human immunodeficiency virus type 1 (HIV-1) gp120, inhibits HIV-1 entry into CD4+ and CD4- cells by two distinct mechanisms. Proc Natl Acad Sci U S A. 1995 May 23;92(11):4867-71. ************************************************************************