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Immune and Viral Outcomes of HIV-1 Therapy Interruption

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luis Montaner, The Wistar Institute
ClinicalTrials.gov Identifier:
NCT00051818
First received: January 16, 2003
Last updated: February 8, 2016
Last verified: December 2005

January 16, 2003
February 8, 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
Not Provided
Complete list of historical versions of study NCT00051818 on ClinicalTrials.gov 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
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Behavioral: Treatment interruption/reinitiation schedule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
17 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051818
5R01AI048398-01, AI048398
Yes
Not Provided
Not Provided
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