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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738569
First Posted: August 20, 2008
Last Update Posted: March 29, 2017
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
  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
HIV Drug: Raltegravir

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Jennifer Brandorff, 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 ]

Secondary Outcome Measures:
  • Measure the change in circulating CD4+ and CD8+ T-lymphocytes [ Time Frame: 12 months ]
  • 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 ]

Enrollment: 30
Actual 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00738569


Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Kenneth A Lichtenstein, MD National Jewish Health
  More Information

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT00738569     History of Changes
Other Study ID Numbers: Merck HIV
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jennifer Brandorff, National Jewish Health:
Chronic inflammation
memory cells
activated t-lymphocytes

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action