Immune and Viral Outcomes of HIV-1 Therapy Interruption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051818
Recruitment Status : Completed
First Posted : January 24, 2003
Last Update Posted : February 9, 2016
Information provided by (Responsible Party):
Luis Montaner, The Wistar Institute

January 16, 2003
January 24, 2003
February 9, 2016
September 2000
May 2003   (Final data collection date for primary outcome measure)
Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression
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Complete list of historical versions of study NCT00051818 on Archive Site
  • 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
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Immune and Viral Outcomes of HIV-1 Therapy Interruption
Immune and Viral Outcomes of HIV-1 Therapy Interruption
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.
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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Behavioral: Treatment interruption/reinitiation schedule
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2003
May 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
5R01AI048398-01( U.S. NIH Grant/Contract )
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Luis Montaner, The Wistar Institute
The Wistar Institute
Not Provided
Principal Investigator: Luis J. Montaner The Wistar Institute
The Wistar Institute
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP