CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
darunavir 800 mg +4 moredrug
Likely dose
darunavir 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00525733
NCT00525733N/ACompleted
CompareCT.gov

A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects

Rockefeller University·interventional·Posted Sep 6, 2007·Updated Mar 9, 2015

In Brief

A clinical study evaluating darunavir 800 mg, FTC 200 mg/TDF 300mg, and 3 other interventions for HIV Infections. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsAaron Diamond AIDS Research Center, Merck Sharp & Dohme LLC, Pfizer

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 6, 2007
Enrollment StartOct 1, 2007
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 18.8 years ago

Interventions

darunavir 800 mgdrug

darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)

FTC 200 mg/TDF 300mgdrug

Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)

Maravirocdrug

Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)

Raltegravirdrug

Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)

Ritonavir 100 mgdrug

one tablet of ritonavir is taken with darunavir daily