Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV
|First Received Date ICMJE||August 4, 2001|
|Last Updated Date||May 17, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00021762 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV|
|Official Title ICMJE||A Pilot Phase II Evaluation of the Effects on HIV Replication of Immunization With a gp120-Depleted, Inactivated Whole Virus Vaccine Combined With Exposures to Replicating Autologous HIV by Scheduled Treatment Interruptions, a Rollover Study of A5057|
The purpose of this study is to see whether or not an HIV vaccination will help the body control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV medicines.
Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV. The vaccine Remune has been shown to boost part of the body's immune response to HIV in patients whose viral load has been lowered with anti-HIV drugs. This study will test the ability of Remune to improve the body's immune response and to lower HIV viral load in patients who stop taking anti-HIV drugs for short periods of time.
Investigators of the pathogenesis of HIV infection agree that one of the most critical questions in HIV disease is why immune responses do not control HIV replication in the vast majority of infected individuals. More specifically, the absence of large lymphocyte proliferation response (LPR) to HIV antigens in these individuals, and their presence in long-term nonprogressors (LTNPs) with a low viral load, requires an investigation of whether a causal relationship exists between LPR to HIV and control of HIV replication. Immunization with Remune has been shown to induce large LPR to HIV antigens when administered to patients in whom HIV replication has been suppressed with antiretroviral therapy (ART). A5120 will evaluate the abilities of immunization with HIV-1 Immunogen and of STIs to enhance immune responses that may control HIV replication in the absence of antiretroviral drugs.
Patients remain in the treatment arm (vaccine versus adjuvant placebo) to which they were randomized on entry to protocol A5057, and both the participant and investigator remain blinded as to the assignment. Patients may receive up to 3 injections of vaccine/adjuvant control in 1 of the following 2 groups.
Arm A: HIV-1 immunogen at study entry and at Week 9 in Step 3 and Step 5. Arm B: HIV-1 immunogen placebo at study entry and at Week 9 in Step 3 and Step 5.
ART is required during Steps 1, 3, 5, and 8 but is not provided by this study. The study is organized into the following series of steps.
Step 1 (ART and injection): receive injection of vaccine/adjuvant control. Patients remain on ART for 6 to 8 weeks.
Step 2 (first STI): all ART is stopped for up to 8 weeks with careful monitoring of viral load and CD4 T cells. Patients whose viral load is controlled may remain on Step 2 for an additional 6 weeks.
Step 3 (resumption of ART): restart ART for 14 weeks. Eligible patients receive an immunization with vaccine/adjuvant control at Week 9.
Step 4 (second STI): identical to Step 2. Step 5 (resumption of ART): identical to Step 3. Step 6 (analytical treatment interruption [ATI]): analytical "read-out" discontinuation of ART for up to 14 weeks.
Step 7 (long-term follow-up without ART): open only to patients with control of viral load who agree to participate in continued treatment withdrawal.
Step 8 (final resumption of ART): patients are followed for 8 weeks on ART to document the effect of restarting ART on suppression of viral load. Patients advance through steps as criteria for HIV RNA level, CD4 count, and treatment are met.
Patients have regular clinic visits for medical/medication histories, physical examinations, and laboratory tests for viral load and immunological parameters.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||HIV Infections|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients may be eligible for this study if they:
Patients will not be eligible for this study if they:
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00021762|
|Other Study ID Numbers ICMJE||A5120
10938 ( Registry Identifier: DAIDS ES Registry Number )
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP