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Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)

NCT00525733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-09

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

darunavir 800 mg

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

DRUG

FTC 200 mg/TDF 300mg

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)

DRUG

Maraviroc

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

DRUG

Raltegravir

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

DRUG

Ritonavir 100 mg

one tablet of ritonavir is taken with darunavir daily

Sponsors & Collaborators

  • Aaron Diamond AIDS Research Center

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Martin Markowitz, MD · Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525733 on ClinicalTrials.gov