drugset / Trial / NCT01013987

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

NCT01013987

Phase 4 Unknown 60 enrolled Fundación Huésped Pfizer · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-02
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 300 mg
Subject Maraviroc Other / unclassified 150 mg
Subject Raltegravir Other / unclassified 400 mg
Subject Ritonavir Other / unclassified 100 mg

Indications