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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000943 |
The purpose of this study is to determine the effects of an HIV vaccine (Remune) on the immune system. This study involves patients who have received at least 60 weeks of anti-HIV therapy, either alone or in combination with IL-2, while enrolled in ACTG 328.
Remune is an experimental HIV vaccine. To see how the body's immune system reacts, this vaccine will be given with 1 to 3 other vaccines, and skin tests will monitor the body's reaction.
Condition | Intervention |
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HIV Infections |
Biological: Tetanus Toxoid Vaccine Biological: Hepatitis A Vaccine (Inactivated) Biological: HIV-1 Immunogen Biological: Hepatitis B Vaccine (Recombinant) |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control |
Official Title: | A Controlled, Pilot Study of the Immunogenicity of Remune in HIV-Infected Subjects Receiving Either Highly Active Antiretroviral Therapy (HAART) Alone or HAART and Interleukin-2 (IL-2): A Nested Substudy of ACTG 328 |
Estimated Enrollment: | 50 |
Proliferative responses to HIV antigens are either absent or of small magnitude in HIV-infected patients, even in the early stages of infection when vigorous proliferative responses to recall antigens are still seen. Remune consists of an inactivated, gp120-depleted virus intended to stimulate HIV-specific immune responses. Remune has been reported to increase lymphocyte proliferative responses to HIV antigens in patients with high CD4 cell counts. Many other T-cell-dependent responses are also impaired in HIV-infected patients, such as after vaccination with hepatitis A or B vaccine. In this study, patients with moderately advanced HIV disease who have already received 52 weeks of either HAART or HAART plus IL-2 are vaccinated with Remune and a control recall immunogen, tetanus toxoid (TT), to evaluate whether these patients can develop new CD4 T-cell and CD8 T-cell responses to HIV-related antigens. The antibody response to hepatitis A and hepatitis B vaccinations also will be explored.
Fifty patients are enrolled in this substudy; 17 from the HAART only arm (Arm I of ACTG 328) and 33 from the HAART plus either CIV or subcutaneous IL-2 arms (Arms II and III of ACTG 328). All patients are vaccinated 3 times with Remune and twice with TT. If patients are hepatitis A total antibody negative, they receive hepatitis A vaccine twice. Additionally, if patients are hepatitis B surface antigen negative, hepatitis B core antibody and surface antibody negative, they receive hepatitis B vaccine 3 times. Patients who are negative for all hepatitis markers receive hepatitis A and B vaccines.
Week 0 of A5046s begins at or after Week 64 of ACTG 328 (for patients in the HAART-only arm) or 4 weeks after the initiation of the seventh or any subsequent IL-2 cycle of ACTG 328 (for patients in any of the IL-2-containing arms). [AS PER AMENDMENT 9/16/99: Patients can be screened through Week 124 of ACTG 328.] Patients receive Remune at Weeks 0, 8, and 16 and TT at Weeks 0 and 8. Hepatitis A and/or B vaccines are also given at these times, if indicated. Blood and skin tests are performed at Weeks 0, 8, 16, and 24 to measure immune response and lymphocyte proliferative responses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
Harbor UCLA Med Ctr | |
Torrance, California, United States, 90502 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Iowa | |
Univ of Iowa Hosp and Clinic | |
Iowa City, Iowa, United States, 52242 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
Univ of Texas Galveston | |
Galveston, Texas, United States, 775550435 |
Study Chair: | Hernan Valdez | |
Study Chair: | Michael Lederman |
Study ID Numbers: | ACTG A5046s, ACTG 328 (Main Study), AACTG A5046s |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000943 |
Health Authority: | United States: Federal Government |
Lymphocytes Interleukin-2 Drug Therapy, Combination AIDS Vaccines CD4 Lymphocyte Count |
Cell Division HIV Core Protein p24 Anti-HIV Agents HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity Interleukin-2 HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents |