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OpenTrials
Completed

NCT Number: NCT00738569

Assess the Downregulation of HIV-1 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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir

Drug

Raltegravir 400 mg PO BID for 12 months

Other names: Brand name is Isentress

Primary outcomes

  1. Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool

    Time frame: 12 months

Secondary outcomes

  1. Measure the change in circulating CD4+ and CD8+ T-lymphocytes

    Time frame: 12 months

  2. 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

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 20, 2008
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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