Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination
|First Submitted Date ICMJE||September 22, 2000|
|First Posted Date ICMJE||August 31, 2001|
|Last Update Posted Date||May 21, 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 NCT00006291 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||Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination|
|Official Title ICMJE||A Phase II, Randomized, Partially Blinded Trial of Combinations of Potent Antiretroviral Therapy, HIV-Specific Immunizations, and Cycles of Interleukin-2 to Promote Efficient Control of Viral Replication|
|Brief Summary||The purpose of this study is to see if adding an HIV vaccine (ALVAC-HIV vCP1452), IL-2 (interleukin-2, a protein found in the blood that helps boost the immune system), or both to anti-HIV-drug therapy is safe, tolerable, and effective in controlling viral load (level of HIV in the body). (This study has been changed to clarify drug name.) Anti-HIV drugs can help reduce a patient's viral load. However, HIV can still remain in CD4 cells (cells of the immune system that help fight infection). Combining an HIV vaccine, IL-2, or both with anti-HIV drugs may help reduce the number of HIV-infected cells.|
The most important goal for designing future therapeutic interventions is to understand the nature of persistent HIV infection in patients successfully treated with potent antiretroviral therapy and to develop strategies to promote the clearance of these reservoirs or at least long-term suppression of these reservoirs. If latently infected cells are able to persist for a long period (despite effective suppression of de novo infection) primarily because immune clearance is not being adequately stimulated by viral antigen, then HIV-specific immunization is a reasonable strategy to enhance the clearance of these cells. Stimulating effective HIV-specific cellular immune responses at a time when plasma viremia is maximally suppressed also may contribute to the long-term containment of HIV replication on potent antiretroviral therapy. A second component to be evaluated in this trial is whether broad, cyclical activation of T cells with IL-2 will increase the activation of HIV proviral gene expression and thereby render target cells susceptible to immune-mediated clearance. This pathogenesis-based clinical trial will explore the potential for these novel treatment strategies (HIV-specific immunization and IL-2, alone and in combination) to complement the effects of potent antiretroviral therapy by promoting more effective immunologic control of HIV-1 replication.
This study is divided into 3 steps.
STEP I: Patients continue to receive their stable potent antiretroviral therapy and are randomized to 1 of 4 arms:
Arm A: Vaccine placebo [AS PER AMENDMENT 08/23/01: ALVAC]; Arm B: Canarypox HIV-specific immunogen [AS PER AMENDMENT 08/23/01: ALVAC-HIV] (vCP1452); Arm C: 8-week cycles of IL-2 plus vaccine placebo [AS PER AMENDMENT 08/23/01: ALVAC]; Arm D: 8-week cycles of IL-2 plus canarypox HIV-specific immunogen [AS PER AMENDMENT 08/23/01: ALVAC-HIV] (vCP1452).
Patients receive vaccine (or vaccine placebo) injections at Weeks 0, 8, 16, 24, and 48. IL-2 injections are synchronized with vaccine injections. IL-2 is given open-label while vCP1452 is double-blinded. Patients must be on Step I for a minimum of 51 weeks [AS PER AMENDMENT 08/23/01: prior to entry into Step II].
STEP II: Patients stop study medications and interrupt potent antiretroviral therapy for [AS PER AMENDMENT 08/23/01: "6 to 16" has been replaced by the following text: a minimum of 12] weeks. Patients whose viral load during Step II remains [AS PER AMENDMENT 08/23/01: at or] below 5,000 copies/ml [AS PER AMENDMENT 08/23/01: and whose CD4 count is 200 cells/mm3 or more] are encouraged to remain off antiretroviral medications and continue viral-load monitoring for up to an additional 10 weeks. These patients are followed [AS PER AMENDMENT 08/23/01: "for up to 16 weeks" has been replaced by the following text: through Week 74] on Step II and must register to Step III only if their viral load increases to 50,000 copies/ml or greater, their CD4 count decreases to below 200 cells/mm3, or if their primary care physician recommends resuming antiretrovirals.
STEP III: Patients resume their original potent antiretroviral therapy regimen for 6 to 10 weeks and are monitored for a minimum of 6 weeks. If patients do not achieve a viral load below 50 copies/ml during those 6 weeks, they continue to be monitored for up to an additional 4 weeks until this degree of suppression is achieved with the same potent antiretroviral therapy regimen or another appropriate regimen.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Masking: Double
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||Completed|
|Completion Date||October 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients may be eligible to enter this study if they:
Patients may not be eligible for this study if they:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Puerto Rico, United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00006291|
|Other Study ID Numbers ICMJE||A5024
10070 ( Registry Identifier: DAIDS ES Registry Number )
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||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