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Immune and Viral Outcomes of HIV-1 Therapy Interruption



Immune and Viral Outcomes of HIV-1 Therapy Interruption

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV.
Details: Our preliminary studies have shown that structured treatment interruption of highly active antiretroviral therapy (HAART) may boost patients’ immune responses to HIV-1. In this study, we will test the hypothesis that repeated structured treatment interruptions will increase HIV-1 immunity and result in better control of viral replication than in controls. We will test this hypothesis by determining time to viral rebound after withdrawal of antiretroviral therapy in a randomized, non-blinded study of a well-characterized subject population from a single center. Patients in this study will be randomized to either treatment interruption or control groups. Patients will be monitored for adherence to therapy and changes in immune status following HAART interruption. CD4 percentage, CD 4 and CD8 mediated anti-HIV-1 responses, cell surface T-cell antigen expression, and thymic function will be assessed.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 17 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV-1 positive - HIV RNA < 500 copies/ml on a regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) and either one protease inhibitor (PI) or one nonnucleoside reverse transcriptase inhibitor (NNRTI) for 6 months prior to study entry - HIV RNA < 50 copies/ml at study screening - CD4 > 400 cells/mm3 with CD4 nadir of > 100 cells/mm3 - Agree to Medication Event Monitoring System monitoring of one component of antiretroviral regimen - HIV-1 viral load >10,000 copies/ml at any time prior to initiating the current uninterrupted HAART regimen - Willing to abstain from all immunomodulatory drugs during the study
Total Enrollment: 42

Location and Contact Information:

Overall Study Official:
LuisMontaner,  Principal Investigator,  The Wistar Institute

The Wistar Institute
Philadelphia,  Pennsylvania,  19104
United States
 


Additional Information:
Study ID Numbers:  5R01AI48398-01;  5R01AI048398-03
Study Start Date: September 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051818

Other Hiv Infections Studies:
1. The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys

2. A Study of Amprenavir in Patients with Protease Inhibitor-Related Complications

3. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers

4. Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

5. A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients

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