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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: | NCT00005758 |
The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500 copies/ml. (This study is currently being redesigned and the purpose may be revised.) Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that it cannot be measured). This study originally added an HIV vaccine called Remune to treat patients. Remune was thought to reduce viral load and improve immune responses. However, new information suggests that Remune may not be as effective as was first believed. The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy. The substudy will look at the effect of another HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about the safety of these vaccines in HIV-positive patients will be gathered.
Condition | Intervention | Phase |
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HIV Infections |
Biological: ALVAC(2)120(B,MN)GNP (vCP1452) Biological: HIV-1 Immunogen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effect of Immunization With an HIV Immunogen on the Time to Virologic Relapse in Individuals Receiving Potent, Suppressive Antiretroviral Therapies |
Estimated Enrollment: | 472 |
Studies have shown that inactivated, gp120-depleted whole virus immunogen (Remune) boosts immune responses to HIV. One response, lymphocyte proliferative response (LPR) to p24, is correlated with a low viral load in some patients with long-term non-progression of disease. This study examines whether administering Remune vaccine may generate new immune responses or boost existing responses to keep the level of virus in the blood low for a longer period of time than antiretroviral therapy alone. [AS PER AMENDMENT 7/20/00: In a recent study using Remune, comparison of virologic failure and time to virologic failure between Remune and adjuvant placebo arms revealed no differences between the 2 arms of the study. Results of this study suggest that the hypothesis in A5057 (that recipients of Remune would have only 50 percent of the number of virologic relapses as occur in the control arm) is no longer plausible in its current design. This protocol is being redesigned.] A substudy adds the HIV canarypox vaccine (vCP1452) in patients in the parent study and evaluates whether canarypox vaccine can augment the immune responses of Remune.
Patients will add either Remune (Arm A), or the placebo Incomplete Freund's Adjuvant (Arm B), to their antiretroviral therapy. They will be stratified to
1 of the following 4 groups:
An immunological substudy will randomize 80 of the eligible volunteers from the study cohort to additionally receive ALVAC vCP1452 or placebo (ALVAC) with equal probability. Arm A will receive ALVAC vCP1452; Arm B will be administered placebo.
[AS PER AMENDMENT 7/20/00: The study is closed to accrual except for patients who enroll into A5058s until the protocol can be redesigned. Patients enrolled under Version 1.0 continue to be followed every 12 weeks (plus or minus 14 days) until the end of the study. Patients should continue taking the same potent antiretroviral treatment that they were taking at study entry until reaching the primary endpoint of first virologic relapse.]
Ages Eligible for Study: | 14 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:
Study Chair: | Fred Valentine | |
Study Chair: | Laurence Peiperl |
Study ID Numbers: | ACTG A5057, A5058s, AACTG A5057 |
Study First Received: | May 23, 2000 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00005758 History of Changes |
Health Authority: | United States: Federal Government |
T-Lymphocytes, Helper-Inducer Combined Modality Therapy HIV Envelope Protein gp120 AIDS Vaccines RNA, Viral |
HIV Core Protein p24 T-Lymphocytes, Cytotoxic Anti-HIV Agents Viral Load HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |