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Immune and Viral Outcomes of HIV-1 Therapy Interruption

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

Condition Intervention Phase
HIV Infections
Behavioral: Treatment interruption/reinitiation schedule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immune and Viral Outcomes of HIV-1 Therapy Interruption

Resource links provided by NLM:

Further study details as provided by The Wistar Institute:

Primary Outcome Measures:
  • Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression

Secondary Outcome Measures:
  • 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

Enrollment: 20
Study Start Date: September 2000
Study Completion Date: July 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00051818

United States, Pennsylvania
The Wistar Institute
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
The Wistar Institute
Principal Investigator: Luis J. Montaner The Wistar Institute
  More Information

Responsible Party: Luis Montaner, Professor and Director, HIV-1 Immunopathogenesis Laboratory, The Wistar Institute Identifier: NCT00051818     History of Changes
Other Study ID Numbers: 5R01AI048398-01  AI048398 
Study First Received: January 16, 2003
Last Updated: February 8, 2016
Health Authority: United States: Federal Government

Keywords provided by The Wistar Institute:
chronic HIV infection
treatment interruption
HIV-specific immune response
immune response
virological response
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on October 20, 2016