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

Sponsor:	National Jewish Health
Collaborator:	Merck
Information provided by:	National Jewish Health
ClinicalTrials.gov Identifier:	NCT00738569

Purpose

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.

Condition	Intervention
Acquired Immunodeficiency Syndrome	Drug: Raltegravir

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Memory

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by National Jewish Health:

Primary Outcome Measures:

Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure the change in circulating CD4+ and CD8+ T-lymphocytes [ Time Frame: 12 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: 12 months ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	July 2008
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Raltegravir	Drug: Raltegravir Raltegravir 400 mg PO BID for 12 months Other Name: Brand name is Isentress

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738569

Locations

United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206

Sponsors and Collaborators

National Jewish Health

Merck

Investigators

Principal Investigator:

Kenneth A Lichtenstein, MD

National Jewish Health

More Information

No publications provided

Responsible Party:	Kenneth A Lichtenstein, MD, National Jewish Health
ClinicalTrials.gov Identifier:	NCT00738569 History of Changes
Other Study ID Numbers:	Merck HIV
Study First Received:	August 19, 2008
Last Updated:	March 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by National Jewish Health:

Chronic inflammation
memory cells
activated t-lymphocytes

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Inflammation
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012