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Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses

NCT00460382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2010-09-17

No results posted yet for this study

Summary

The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.

Conditions

  • HIV Infections

Interventions

DRUG

raltegravir potassium

400 mg twice a day

DRUG

darunavir/ritonavir

2 pills of 300 mg twice a day

DRUG

etravirine

2 pills of 100 mg twice a day

DRUG

Optimized background regimen

NRTIs and or enfuvirtide (investigator choice)

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Janssen-Cilag Tibotec

    collaborator UNKNOWN

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Yazdan YAZDANPANAH, MD PHD · Hôpital Tourcoing FRANCE

  • Geneviève CHENE, MD PHD · INSERM U897 BORDEAUX FRANCE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-03-31
Completion
2009-09-30

Countries

  • France

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 NCT00460382 on ClinicalTrials.gov