Immune and Viral Outcomes of HIV-1 Therapy Interruption

• ClinicalTrials.gov Identifier: NCT00051818
• Recruitment Status: Completed
• First Posted: January 24, 2003
• Last Update Posted: February 9, 2016
• Sponsor: The Wistar Institute
• Information provided by (Responsible Party): Luis Montaner, The Wistar Institute

Tracking Information

• First Submitted Date: January 16, 2003
• First Posted Date: January 24, 2003
• Last Update Posted Date: February 9, 2016
• Study Start Date: September 2000
• Actual Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 6, 2005): Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: December 6, 2005)

• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immune and Viral Outcomes of HIV-1 Therapy Interruption
• Official Title: Immune and Viral Outcomes of HIV-1 Therapy Interruption
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infections
• Intervention: Behavioral: Treatment interruption/reinitiation schedule
• Study Arms: Not Provided

Publications *

• Montaner LJ. Structured treatment interruptions to control HIV-1 and limit drug exposure. Trends Immunol. 2001 Feb;22(2):92-6. Review.
• Papasavvas E, Kostman JR, Mounzer K, Grant RM, Gross R, Gallo C, Azzoni L, Foulkes A, Thiel B, Pistilli M, Mackiewicz A, Shull J, Montaner LJ. Randomized, controlled trial of therapy interruption in chronic HIV-1 infection. PLoS Med. 2004 Dec;1(3):e64. Epub 2004 Dec 28.
• Papasavvas E, Grant RM, Sun J, Mackiewicz A, Pistilli M, Gallo C, Kostman JR, Mounzer K, Shull J, Montaner LJ. Lack of persistent drug-resistant mutations evaluated within and between treatment interruptions in chronically HIV-1-infected patients. AIDS. 2003 Nov 7;17(16):2337-43.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 8, 2016): 20
• Original Enrollment (submitted: June 23, 2005): 42
• Actual Study Completion Date: July 2003
• Actual Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 17 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00051818
• Other Study ID Numbers: 5R01AI048398-01( U.S. NIH Grant/Contract ); AI048398
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Luis Montaner, The Wistar Institute
• Study Sponsor: The Wistar Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Luis J. Montaner; The Wistar Institute

• PRS Account: The Wistar Institute
• Verification Date: December 2005