Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women
| Status: | Archived |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2011 |
| End Date: | December 2013 |
Open Label, Randomized Trial of TDF/FTC+Raltegravir Vs. TDF/FTC+Efavirenz in HIV-1-Infected Women: Differential Effects on Viral Suppression/Reservoir, & Immune Parameters in Different Compartments, Including Gut & Genital Tract
Raltegravir not only has a unique mechanism of action, but may also have other unique
effects on suppression of viral replication, viral reservoir, and immune reconstitution in
blood and other important compartments. This may in part be due to the pharmacokinetics of
Raltegravir in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug
in this study, with both drugs being used as part of a three-drug regimen with tenofovir and
emtricitabine.
The primary objectives are to determine differences in the effects of 2 anti-retroviral
regimens, Raltegravir + Truvada versus Atripla, with respect to:
1. Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ
hybridization).
2. Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract.
3. Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine
profiles.
The secondary objective is to determine the pharmacokinetics of Raltegravir in blood and gut
tissue; relative tissue/compartment penetration compared to Efavirenz.
This is a phase III, prospective, randomized (1:1), multicenter, open label study comparing
the effects of two HAART regimens:
- Arm A: Raltegravir 400 mg PO BID + TDF/FTC (Truvada, 300/200 mg) One PO Daily
- Arm B: Efavirenz + TDF/FTC (Atripla) Once PO Daily
The following local sites: Mt. Sinai, Rush University Medical Center, Stroger Hospital,
University of Chicago and University of Illinois will work together to enroll 10 eligible
women meeting all eligibility criteria (5 per study arm) over a one year time period. These
10 women will be randomized 1:1 to receive either TDF/FTC + Raltegravir or TDF/FTC +
Efavirenz (Atripla). There will be 2 baseline evaluations prior to initiation of study
therapy. Subjects will be followed for 48 weeks after initiation of study treatment.
We found this trial at
5
sites
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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