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

National Jewish Health30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

HIV

Interventions

RaltegravirDRUG

Raltegravir 400 mg PO BID for 12 months

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Jewish Health

Denver, Colorado, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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