Immune and Viral Outcomes of HIV-1 Therapy Interruption

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immune and Viral Outcomes of HIV-1 Therapy Interruption

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Treatment interruption/reinitiation schedule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Treatment interruption/reinitiation schedule|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of sequential STIs |  |  | 
| changes in immune reconstitution in relation to sequential STIs, including CD4 T-cell changes, recall responses, and T-cell activation, as measured by cell surface antigen changes |  |  | 
| genotypic changes occurring in HIV-1 protease and reverse transcriptase regions after sequential STIs and their relation to clinical failure under the ART regimen at study entry |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic HIV infection, treatment interruption, HIV-specific immune response, immune response, virological response, treatment experienced