Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women
Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Rush University Medical Center
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Efavirenz Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Raltegravir Potassium