Immune and Viral Outcomes of HIV-1 Therapy Interruption

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00051818

First Posted: January 24, 2003

Last Update Posted: February 9, 2016

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.

Information provided by (Responsible Party):

Luis Montaner, The Wistar Institute

Purpose

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Immune and Viral Outcomes of HIV-1 Therapy Interruption

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Luis Montaner, 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.

Eligibility

Information from the National Library of Medicine

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051818

Locations


United States, Pennsylvania
The Wistar Institute
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

The Wistar Institute

Investigators


Principal Investigator:	Luis J. Montaner	The Wistar Institute

More Information

Publications:

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.

Montaner LJ. Structured treatment interruptions to control HIV-1 and limit drug exposure. Trends Immunol. 2001 Feb;22(2):92-6. Review.


Responsible Party:	Luis Montaner, Professor and Director, HIV-1 Immunopathogenesis Laboratory, The Wistar Institute
ClinicalTrials.gov Identifier:	NCT00051818 History of Changes
Other Study ID Numbers:	5R01AI048398-01 ( U.S. NIH Grant/Contract ) AI048398
First Submitted:	January 16, 2003
First Posted:	January 24, 2003
Last Update Posted:	February 9, 2016
Last Verified:	December 2005

Keywords provided by Luis Montaner, 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

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