Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT00738569
First received: August 19, 2008
Last updated: April 1, 2014
Last verified: April 2014

August 19, 2008
April 1, 2014
July 2008
February 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00738569 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV
Drug: Raltegravir
Raltegravir 400 mg PO BID for 12 months
Other Name: Brand name is Isentress
Experimental: Raltegravir
Intervention: Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least 18 years of age
  2. HIV-positive by Western blot or viral load
  3. Viral load < 400 copies/ml
  4. 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:

  1. 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
  2. Viral load > 400 copies/ml
  3. Allergy or resistance to raltegravir
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00738569
Merck HIV
No
Jennifer Brandorff, National Jewish Health
National Jewish Health
Merck Sharp & Dohme Corp.
Principal Investigator: Kenneth A Lichtenstein, MD National Jewish Health
National Jewish Health
April 2014

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