Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
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|ClinicalTrials.gov Identifier: NCT00056797|
Recruitment Status : Completed
First Posted : March 25, 2003
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: ALVAC HIV vaccine (vCP1452) Drug: Interleukin-2||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||92 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy (HAART).|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- 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
- Proportion of subjects who relapse during the first 12 weeks following cessation of HAART
- length of time to the termination of Step II
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056797
|United States, New York|
|NY Presbyterian Weill Cornell Medical Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Kendall A. Smith, MD||Weill Medical College of Cornell University|