Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
The researchers are involved in a phase II, randomized, two-arm study, comparing the
efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with
Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and
raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women.
Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the
investigator and patient that continued therapy is in the patient's best interest.
Hypotheses:
- Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination
with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral
replication.
- Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect
to immune reconstitution in peripheral blood and in the gastrointestinal mucosa.
- Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with
respect to tolerability.
Phase:
N/A
Details
Lead Sponsor:
Rockefeller University
Collaborators:
Aaron Diamond AIDS Research Center Merck Sharp & Dohme Corp. Pfizer