Immune and Viral Outcomes of HIV-1 Therapy Interruption - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00051818

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immune and Viral Outcomes of HIV-1 Therapy Interruption

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Estimated Enrollment:	42
Study Start Date:	September 2000

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

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051818

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study ID Numbers:	5R01AI48398-01, 5R01AI048398-03
Study First Received:	January 16, 2003
Last Updated:	December 6, 2005
ClinicalTrials.gov Identifier:	NCT00051818 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

chronic HIV infection
treatment interruption
HIV-specific immune response

immune response
virological response
treatment experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on July 02, 2009