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

National Jewish Health

Status: Completed

Conditions: HIV

Treatments: Drug: Raltegravir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00738569

Merck HIV

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Raltegravir

Experimental group

Treatment:

Drug: Raltegravir