Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen - Tabular View

Tracking Information

First Received Date ^ICMJE

August 19, 2008

Last Updated Date

February 4, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00738569 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure the change in circulating CD4+ and CD8+ T-lymphocytes [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Determine whether the circulating CD8+ T-lymphocyte count or the CD4+/CD8+ ratio can serve as a surrogate marker for suppression of chronic inflammation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Official Title ^ICMJE

A Pilot Study to Assess the Downregulation of HIV-1 Associated Chronic Inflammation in Patients With Limited Immunologic Responses When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Brief Summary

The purpose of this study is to determine whether or not adding Raltegravir to a fully suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

HIV-1

Intervention ^ICMJE

Drug: Raltegravir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

At least 18 years of age
HIV-positive by Western blot or viral load
Viral load < 400 copies/ml
CD4+ T-lymphocyte count less than 350 cells/mm3 or change in CD4+ T-lymphocyte count < 100 cells/mm3 for at least one year on stable HAART with viral load < 400 copies/ml for the same period of time

Exclusion Criteria:

CD4+ T-lymphocyte count greater than or equal to 350 cells/mm3 or rise in CD4+ T-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry
Viral load > 400 copies/ml
Allergy or resistance to raltegravir

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kenneth A Lichtenstein, MD	303-398-1552	lichtensteink@njc.org
Contact: Holly O'Brien, RN	303-398-1966	obrienh@njc.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00738569

Responsible Party

Kenneth A Lichtenstein, MD, National Jewish Health

Study ID Numbers ^ICMJE

Merck HIV

Study Sponsor ^ICMJE

National Jewish Health

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Kenneth A Lichtenstein, MD

National Jewish Health

Information Provided By

National Jewish Health

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP