Date: Mon, 5 Aug 1996 19:41:26 -0400 From: "Flynn Mclean" Subject: New Information from ACTIS 08/05/96 (1 of 2) August 5, 1996 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 5 recent clinical trials 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: NIAID DATRI 016. TITLE: A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection. PHASE: Pilot Study. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infection. 2. CD4 count 50-200 cells/mm3. 3. No ongoing major opportunistic infections. 4. On stable antiretroviral therapy for the past 2 months. 5. Has an HLA-single haplotype matched, single haplotype mismatched parent, sibling, or adult offspring who is ABO, Rh compatible to serve as an HIV-negative lymphocyte donor. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 count 50-200 cells/mm3. 3. No ongoing major opportunistic infections. 4. Been on stable antiretroviral therapy for the past 2 months. 5. Tonsils present. 6. Life expectancy greater than 6 months. 7. An HLA-single haplotype matched, single haplotype mismatched parent, sibling, or adult offspring who is ABO, Rh compatible to serve as an HIV-negative lymphocyte donor. AGE: 18 Years - 50 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test. Abstinence or agree to use barrier methods of birth control / contraception during the study. PRIOR MEDICATION: Required: Stable antiretroviral therapy for at least 2 months prior to study entry. CONCURRENT MEDICATION: Required: Stable antiretroviral therapy. Allowed: Maintenance therapy for a controlled opportunistic infection. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 10.0 g/dl. PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: 50 - 200 cells/mm3. ( 100 - 200 ). SGPT (ALT): <= 5 x ULN. (ULN = upper limit of normal). CREATININE: <= 2.0 mg/dl. OTHER LABORATORY VALUES: Alkaline phosphatase <= 5 x ULN. PT/PTT no more than 2 seconds above ULN. PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 17 Years. 51 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. RISK BEHAVIOR: Active substance abuse. PRIOR TREATMENT: Excluded: Blood transfusion within the past 2 months. CONCURRENT MEDICATION: Excluded: 1. GM-CSF or G-CSF. 2. Any investigational drug. 3. Immunomodulators (such as interferon, steroids, topical corticosteroids, thalidomide, pentoxyfylline, IL-2). 4. Nonsteroidal anti-inflammatory drugs. 5. Aspirin. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Lymphoma or other malignancy requiring chemotherapy. 2. Bleeding disorder that would preclude a tonsillar biopsy. 3. Antibody on donor/recipient lymphocyte reactive antibody assay. Donors with the following symptoms or conditions are excluded: 1. Medical condition that would endanger health of donor or recipient. 2. Failure to meet established donor standards on blood screening tests. 3. CMV seropositivity if the patient (recipient) is CMV seronegative. 4. Pregnancy. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity or adverse reactions. 2. Development of any malignancy other than KS or cutaneous basal cell or squamous cell carcinoma. 3. Development of a major opportunistic infection or any other major infections. 4. Pregnancy. 5. Donor withdrawal. 6. Requirement for disallowed medications. PARTICIPATING UNITS ------------------- 0000001670: University Hosp of Cleveland / Case Western Reserve Univ 2061 Cornell Road Cleveland, OH 44106 Contact: Michael Chance (216) 844-8051 Contact: (216) 844-8175 OPEN 960731. ******************************************************************** PROTOCOL NUMBER: NIAID ACTG 304. TITLE: A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA. PHASE: OTHER. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Documented HIV infection. 2. CD4 count <= 500 cells/mm3 within 14 days prior to study entry. 3. At least 12 months of prior AZT, with 2 months of continuous AZT monotherapy immediately prior to study. 4. Discontinuing AZT because of drug-related toxicity, unwanted side effects, or the need to meet entry requirements on another research study. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 count <= 500 cells/mm3. 3. At least 12 months of prior AZT, with 2 months of continuous AZT monotherapy immediately prior to study. 4. The need to discontinue AZT because of drug-related toxicity or unwanted side effects or as an entry requirement for another research study. 5. Consent of parent or guardian if < 18 years old. AGE: 13 Years - 99 Years. SEX: M. F. CONCURRENT MEDICATION: Allowed: 1. Maintenance therapy for opportunistic infection, provided patient has received at least 1 month of stable therapy prior to study. 2. G-CSF. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: <= 500 cells/mm3. ( 0 - 100 - 200 - 300 - 400 - 500 ). PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 12 Years. PRIOR MEDICATION: Excluded within the past 2 months: 1. Antiretrovirals other than AZT. 2. Systemic immunomodulators (e.g., gp120, gp160, IL-2, and interferons). Excluded within the past month: Vaccination. CONCURRENT MEDICATION: Excluded: Therapy for an acute opportunistic infection. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: Current medical status that is considered unsuitable for study participation. END POINT --------- Changes in plasma HIV-1 RNA levels. PARTICIPATING UNITS ------------------- 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 960409 ACTU: 2701. 0000001366: Rush Presbyterian - Saint Luke's Medical Center 600 South Paulina Street / Suite 143 Chicago, IL 60612 Contact: Lisa Pitler (312) 942-4810 OPEN 960703 ACTU: 2702. 0000001357: Johns Hopkins University Hospital 1830 East Monument Street / Room 8074 Baltimore, MD 21205-2196 Contact: Becky Becker (410) 955-4370 OPEN 960222 ACTU: 0201. 0000001334: SUNY / Erie County Medical Center at Buffalo 462 Grider Street / Suite 35 Buffalo, NY 14215 Contact: Holly Ingelfinger-Lopez (716) 898-4119 OPEN 960201 ACTU: 1102. 0000001310: University of Rochester Medical Center 601 Elmwood Avenue / P O Box 689 Rochester, NY 14642 Contact: Carol Greisberger (716) 275-2740 OPEN 960301 ACTU: 1101. 0000001307: Ohio State University Hospital Clinic 456 West 10th Avenue / Room 4725 Columbus, OH 43210-1228 Contact: Judy Neidig (614) 293-8112 Contact: (614) 293-5282 OPEN 960123 ACTU: 2301. 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 CLOSED 960522 ACTU: 2501. 0000001285: University of Washington 1001 Broadway / Suite 218 Seattle, WA 98122-4304 Contact: Jeanne Conley (206) 223-3184 OPEN 860329 ACTU: 1401. ******************************************************************* PROTOCOL NUMBER: NIAID ACTG 315. TITLE: A Pilot Study to Evaluate the Immunologic Consequences of a Highly Active Antiretroviral Therapy Regimen ( HAARTR ) Consisting of Ritonavir ( ABT-538 ), Zidovudine ( AZT ), and Lamivudine ( 3TC ) in Moderately Advanced HIV-1 Disease. PHASE: Pilot Study. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Documented HIV infection. 2. CD4 count 100 - 300 cells/mm3 between 42 and 70 days prior to study entry. 3. At least 3 consecutive months of prior AZT at a dosage of 500-600 mg BID, but with 5 weeks of antiretroviral washout prior to study entry. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. CD4 count 100 - 300 cells/mm3. 3. At least 3 consecutive months of prior AZT at a dosage of 500-600 mg BID, but with 5 weeks of antiretroviral washout prior to study entry. 4. Consent of parent or guardian if less than 18 years old. AGE: 16 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test. Abstinence or agree to use barrier methods of birth control / contraception during the study. CONCURRENT TREATMENT: Allowed: 1. Acupuncture. 2. Visualization techniques. PRIOR MEDICATION: Required: 1. Prior AZT at 500-600 mg BID at any time. 2. PCP prophylaxis during antiretroviral washout. Allowed: 1. Prior ddI and/or ddC. 2. Prior recombinant erythropoietin and/or G-CSF for AZT-related bone marrow suppression. CONCURRENT MEDICATION: Allowed: 1. Recombinant erythropoietin and/or G-CSF for AZT-related bone marrow suppression. 2. Antibiotics other than metronidazole. 3. PCP prophylaxis. 4. Regularly prescribed medications such as antipyretics, analgesics, allergy medicine, and oral contraceptives. 5. Vitamins and herbal therapies. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: > 9.0 g/dl. (women); > 9.5 g/dl (men). PLATELET COUNT: > 20000 platelets/mm3. CD4 (T4 CELL) COUNT: 100 - 300 cells/mm3. ( 100 - 200 - 300 ). BILIRUBIN: < ULN mg/dl. (ULN = upper limit of normal). SGOT (AST): < 3.0 x ULN. SGPT (ALT): < 3.0 x ULN. CREATININE: < 1.5 x ULN. KARNOFSKY: >= 80. OTHER LABORATORY VALUES: Absolute neutrophils > 1000 cells/mm3. Alkaline phosphatase < 3.0 x ULN. Fasting triglyceride < 400 mg/dl. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Active opportunistic infection or febrile illness with temperature >= 38.5 C within 3 days prior to study entry. 2. History of acute pancreatitis within the past 2 years. AGE: 01 Days - 15 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. RISK BEHAVIOR: Active substance abuse. PRIOR MEDICATION: Excluded: 1. Prior 3TC or a protease inhibitor. 2. Experimental drugs except those for HIV-related conditions, within the past 30 days. CONCURRENT MEDICATION: Excluded: 1. Immunomodulators such as systemic corticosteroids, thalidomide, or cytokines. 2. Rifabutin. 3. Disulfiram (Antabuse) or other medications with similar effects, including metronidazole. 4. Other drugs contraindicated with ritonavir. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Chronic pancreatitis. 2. Psychological conditions that would affect compliance. 3. Intolerance to 500-600 mg/day AZT. 4. Concurrent participation on another antiretroviral research treatment study (study treatment for opportunistic infection or complications of HIV is allowed). 5. Considered likely to be noncompliant on study. GENERIC DRUG NAME ----------------- Drug 1: Ritonavir. Protease inhibitor. Drug 2: Zidovudine. Antiretroviral. Drug 3: Lamivudine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: ABT-538. Drug 2: Retrovir. Drug 3: 3TC. DRUG COMPANIES -------------- Drug 1: Abbott Laboratories One Abbott Park Road Abbott Park, IL 60064 Contact: Ritonavir Information (800) 441-4987. 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: 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 --------- Immune responses. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Generalized debilitation or entry into a nursing home or hospice such that continuation on study is no longer possible. 2. Unacceptable toxicity. 3. Requirement for disallowed medications. 4. Pregnancy. 5. Further participation deemed detrimental to well being. 6. Patient noncompliance or refusal of further therapy. 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 960305 ACTU: 6101. 0000001366: Rush Presbyterian - Saint Luke's Medical Center 600 South Paulina Street / Suite 143 Chicago, IL 60612 Contact: Lisa Pitler (312) 942-4810 OPEN 960305 ACTU: 2702. 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 960306 ACTU: 2501. Date: Mon, 5 Aug 1996 18:47:01 -0400 From: "Flynn Mclean" Subject: New Information from ACTIS 08/05/96 (2 of 2) New Information from ACTIS August 5, 1996 2 of 2 **************************************************************** PROTOCOL NUMBER: NIAID ACTG 333. TITLE: The Antiviral Effect of Switching From Hard Capsule Saquinavir to the Soft Gelatin Capsule of Saquinavir Versus Switching to Indinavir After 1 Year of Saquinavir Use. PHASE: Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Documented HIV infection. 2. Received more than 1 year of hard capsule saquinavir at 1800 mg/day. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. Prior hard capsule saquinavir at 1800 mg/day for more than 1 year. AGE: 18 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 during the study and for 90 days after. CONCURRENT TREATMENT: Allowed: 1. Acupuncture. 2. Visualization techniques. PRIOR MEDICATION: Allowed: 1. Prior saquinavir. 2. Prior antiretrovirals, excluding protease inhibitors other than saquinavir. CONCURRENT MEDICATION: Required: PCP prophylaxis if CD4 count <= 200 cells/mm3. Allowed: 1. Intralesional therapy for KS. 2. Vitamins. 3. Nucleoside RT inhibitors, provided regimen remains stable for first 8 weeks of study. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: > 8.9 g/dl. (women); > 9.1 g/dl (men). PLATELET COUNT: > 50000 platelets/mm3. CD4 (T4 CELL) COUNT: Unspecified cells/mm3. BILIRUBIN: <= 1.5 x ULN mg/dl. (ULN = upper limit of normal). SGOT (AST): < 5.0 x ULN. SGPT (ALT): < 5.0 x ULN. CREATININE: <= 1.5 x ULN. OTHER LABORATORY VALUES: Absolute neutrophils > 750 cells/mm3. Alkaline phosphatase < 5 x ULN. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Unexplained fever > 38.5 C for any 7 days within 30 days prior to study entry. 2. Diarrhea persisting for 15 days within 30 days prior to study entry. AGE: 01 Days - 17 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 during study and for 90 days after. RISK BEHAVIOR: Active substance abuse that would interfere with study evaluation or procedures. PRIOR MEDICATION: Excluded: 1. Any prior protease inhibitor other than saquinavir. Excluded within the past 2 months. 2. Change in antiretroviral regimen. 3. Systemic chemotherapy for KS. Excluded within the past month: 1. Non-nucleoside RT inhibitors. 2. Interferons. 3. Interleukins. 4. HIV vaccines. 5. Experimental therapies. Excluded within the past 2 weeks: 1. Rifabutin. 2. Cisapride. 3. Terfenadine. 4. Astemizole. 5. Midazolam. 6. Triazolam. 7. Oral ketoconazole. 8. Delavirdine. 9. Acute therapy for infection or other medical illness. CONCURRENT MEDICATION: Excluded: 1. Protease inhibitors other than study drugs. 2. Non-nucleoside RT inhibitors. 3. Interferon. 4. Interleukins. 5. GM-CSF. 6. HIV vaccines. 7. Systemic cytotoxic chemotherapy. 8. Investigational drugs other than study medications. 9. Rifabutin. 10. Rifampin. 11. Midazolam. 12. Triazolam. 13. Ketoconazole. 14. Delavirdine. 15. Cisapride. 16. Terfenadine. 17. Astemizole. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: Psychological condition or medical instability that would interfere with study evaluation or procedures. GENERIC DRUG NAME ----------------- Drug 1: Saquinavir mesylate. Protease inhibitor. Drug 2: Indinavir sulfate. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Invirase. Drug 2: Crixivan. DRUG COMPANIES -------------- Drug 1: Hoffmann - La Roche Incorporated 340 Kingsland Street Nutley, NJ 07110-1199 Contact: Professional Services (800) 526-6367. Drug 2: Merck Research Laboratories 126 East Lincoln Avenue Rahway, NJ 07065 Contact: Unspecified (800) 379-1332 Contact: Dr Paul Deutsch (908) 594-5833. END POINT --------- Plasma HIV RNA levels. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity. 2. Malignancy that requires systemic therapy. 3. Requirement for disallowed medications. 4. Patient noncompliance or desire to withdraw from study. 5. Clinical reasons deemed sufficient for study discontinuation. 6. Pregnancy. PARTICIPATING UNITS ------------------- 0000001380: Stanford at Kaiser / Kaiser Permanente Medical Center 2590 Geary Boulevard San Francisco, CA 94115 Contact: Gretchen Van Raalte (415) 202-3482 Contact: (415) 202-3480 OPEN 960723 ACTU: 0502. 0000001388: Stanford University Medical Center 300 Pasteur Drive / S156 Stanford, CA 94305-5107 Contact: Virginia Tallman (415) 723-2804 Contact: (415) 723-6231 OPEN 960718 ACTU: 0501. 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 960715 ACTU: 6101. 0000001367: University of Miami School of Medicine 1800 Northwest 10th Avenue / P O Box 016960 Miami, FL 33136-1013 Contact: Lisa Rolfe (305) 243-3838 OPEN 960717 ACTU: 0901. 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 960723 ACTU: 1701. 0000001348: Harvard University / Massachusetts General Hospital 55 Fruit Street / Gray 5 Boston, MA 02114 Contact: Ellen Godfrey McCarthy (617) 726-5598 OPEN 960715 ACTU: 0101. 0000001307: Ohio State University Hospital Clinic 456 West 10th Avenue / Room 4725 Columbus, OH 43210-1228 Contact: Judy Neidig (614) 293-8112 Contact: (614) 293-5282 OPEN 960715 ACTU: 2301. 0000001466: Univ TX Galveston Medical Branch Route H-82 / Clay Hall Galveston, TX 77555-0882 Contact: Karen Waterman (409) 772-0361 OPEN 960715 ACTU: 6301. 0000001285: University of Washington 1001 Broadway / Suite 218 Seattle, WA 98122-4304 Contact: Jeanne Conley (206) 223-3184 OPEN 960718 ACTU: 1401. *************************************************************** PROTOCOL NUMBER: NIAID VEU 029. TITLE: Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV ( vCP205 ) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules. PHASE: Phase I. DISEASE STATUS: Volunteers have the following conditions: 1. Normal history and physical exam. 2. Negative ELISA and Western blot for HIV within 8 weeks prior to immunization. 3. CD4 count >= 400 cells/mm3. 4. Normal urine dipstick with esterase and nitrite. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Volunteers must have: 1. Normal history and physical exam. 2. Negative ELISA and Western blot for HIV. 3. CD4 count >= 400 cells/mm3. 4. Normal urine dipstick with esterase and nitrite. 5. Lower risk sexual behavior. AGE: 18 Years - 60 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test. Not breast-feeding. Abstinence or effective method of birth control / contraception including oral contraceptives during the study. LABORATORY VALUES AT ENTRY -------------------------- HEMATOCRIT: >= 34 percent. (women); >= 38 percent (men). PLATELET COUNT: 150000 - 550000 platelets/mm3. CD4 (T4 CELL) COUNT: >= 400 cells/mm3. ( 400 - 500 - 600 - 700 - 800 - plus ). SGPT (ALT): <= 1.5 x ULN. (ULN = upper limit of normal). CREATININE: <= 1.6 mg/dl. OTHER LABORATORY VALUES: WBC >= 3500 cells/mm3 with normal differential. Total lymphocytes >= 800 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Volunteers with the following prior conditions are excluded: 1. History of immunodeficiency, chronic illness, automimmune disease, or use of immunosuppressive medications. 2. History of anaphylaxis or other serious adverse reactions to vaccines. 3. Prior immunization against rabies. 4. History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension). 5. Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance. 6. History of cancer unless there has been surgical excision that is considered to have achieved cure. AGE: 01 Days - 17 Years. 61 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test. Breast-feeding. No abstinence or no agreement to use effective method of birth control / contraception during the study. RISK BEHAVIOR: Identifiable high-risk behavior for HIV infection, such as - injection drug use within past 12 months. - higher or intermediate risk sexual behavior. PRIOR TREATMENT: Excluded: Blood products or immunoglobulin within 6 months prior to study entry. PRIOR MEDICATION: Excluded: 1. Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. 2. Experimental agents within 30 days prior to study entry. 3. Prior HIV vaccines. 4. Prior rabies immunization. CO-EXISTING CONDITIONS OR DISEASES: Volunteers with the following symptoms or conditions are excluded: 1. Positive hepatitis B surface antigen. 2. Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance. 3. Occupational responsibilities that preclude compliance. 4. Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible. 5. Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. 6. Allergy to egg products or neomycin. 7. Occupational exposure to birds. AVAILABILITY: Unavailable for 12 months of follow-up. GENERIC DRUG NAME ----------------- Drug 1: ALVAC-HIV MN120TMG ( vCP205 ). Vaccine. Drug 2: rgp120/HIV-1SF2. Vaccine. Drug 3: ALVAC-RG rabies glycoprotein ( vCP65 ). Vaccine. DRUG COMPANIES -------------- Drug 1: Pasteur Merieux Serums et Vaccins 3 Avenue Pasteur / BP 10 Marnes la Coquette, FR 92430 Contact: Dr Jean-Louis Excler 011-33-147-417-922. Drug 2: BIOCINE Company 4560 Horton Street Emeryville, CA 94608-2916 Contact: Dr Anne-Marie Duliege (510) 601-2715. Drug 3: Pasteur Merieux Serums et Vaccins 3 Avenue Pasteur / BP 10 Marnes la Coquette, FR 92430 Contact: Dr Jean-Louis Excler 011-33-147-417-922. PARTICIPATING UNITS ------------------- 0000003328: University of Alabama at Birmingham 908 20th Street South / CCB 178 / AVEU Clinic Birmingham, AL 35294-2050 Contact: James Raper (205) 975-2840 OPEN 960626 ACTU: 6009. 0000001425: Howard University Hospital / Pediatrics 2041 Georgia Avenue NW Washington, DC 20060 Contact: Dr Helga Finke (202) 865-1248 OPEN 960626 ACTU: 5044. 0000001453: University of Rochester Medical Center 601 Elmwood Avenue / Box 689 Rochester, NY 14642 Contact: Shirley Erb (716) 275-5871 OPEN 960701 ACTU: 6005. ****************************************************************