A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy (HAART).
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25, corresponding to 8 to 12 weeks following the interruption of HAART
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in people with HIV infection.
Detailed Description
While the advent of highly active antiretroviral therapy (HAART) has contributed to the increasing control of HIV infection and viral replication, ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals. This trial will evaluate the use of the ALVAC vCP1452 vaccine in combination with IL-2 to increase HIV-specific immune responses in HIV infected patients. ALVAC vCP1452 vaccine is a recombinant canarypox HIV vaccine that is administered as a monthly intramuscular injection. The IL-2 is self administered as a daily subcutaneous injection at a low, non-toxic dose (2 million units). Participants in this study are randomized to receive either ALVAC and IL-2 or placebo for the first 3 months of the study. During this time, participants will continue on their current antiretroviral medications and have monthly study visits. Study visits will include a brief medical interview and physical exam, administration of the vaccine, and blood tests. At the end of 3 months, participants will discontinue both their study medications (IL-2 and ALVAC or placebo) and their antiretroviral medications. This Diagnostic Treatment Interruption (DTI) will continue for a minimum of 3 months. During the DTI, participants will have weekly study visits in which viral and lymphocyte dynamics are monitored.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25, corresponding to 8 to 12 weeks following the interruption of HAART
Secondary Outcomes
- length of time to the termination of Step II
- Proportion of subjects who relapse during the first 12 weeks following cessation of HAART
- changes in frequency, activation state, and HIV-specific functional capacity of T cells and NK cells in blood, as monitored by the expression of intracellular cytokines during the first 12 weeks after cessation of HAART