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Maraviroc (Celsentri) With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients

NCT01013987 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-02-10

No results posted yet for this study

Summary

Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.

The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.

Conditions

  • HIV-1 Adults Patients
  • AIDS
  • Triple Class Failure

Interventions

DRUG

maraviroc

maraviroc: one 150 mg pill twice daily

DRUG

Raltegravir

raltegravir : one 400 mg pill twice daily

DRUG

Darunavir/ritonavir

* darunavir : two 300 mg pills twice daily with meal * ritonavir: one 100 mg pill twice daily with meal

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Fundación Huésped

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28

Countries

  • Argentina

More Related Trials

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 NCT01013987 on ClinicalTrials.gov