Immune and Viral Outcomes of HIV-1 Therapy Interruption

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00051818
• Lead Sponsor: The Wistar Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2003-01-16
• Study First Submitted QC: 2003-01-23
• Study First Posted: 2003-01-24
• Primary Completion: 2003-05
• Study Completion: 2003-07
• Status Verified: 2005-12
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Wistar Institute; 🇺🇸 Philadelphia, Pennsylvania, United States