HIV
Conditions
Keywords
Chronic inflammation, memory cells, activated t-lymphocytes
Brief summary
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.
Interventions
DRUGRaltegravir
Raltegravir 400 mg PO BID for 12 months
Sponsors
Merck Sharp & Dohme LLC
National Jewish Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Measure the change in circulating CD4+ and CD8+ T-lymphocytes | 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 | 12 months |
Countries
United States
Outcome results
None listed