NCT01013987

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

A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fundación Huésped · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 4, single arm, open-label, study designed to demonstrate the safety, tolerability, efficacy, antiviral and immunological activity of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir in patients with limited to no treatment option in HIV-1 infected subjects ≥ 21 years old. The trial population will comprise 60 HIV-infected subjects with history of triple class antiretroviral failure, naïve to CCR5-inhibitors, integrase-inhibitors and darunavir will be evaluated. Single arm, stratified according to plasma viral load at screening (\> or \< 100,000 copies/ml). Those with evidence of R5 viruses and susceptibility to darunavir in the resistance testing analysis, plus history of failure to NRTIs, NNRTIs and at least one PI, plus a genotype analysis showing evidence of resistance to NRTIs (at least 2 TAMS and/or Q151M and or 69ss), resistance to PIs (at least 2 major mutations), will start a regimen of maraviroc, raltegravir and ritonavir boosted darunavir. This trial will consist of a screening period of up to 6 weeks, a 48-week treatment period, with interim analysis at 16 and 24 weeks. Followed by a 4-week post-treatment follow-up (FU) period. Virologic response, CD4 count change, clinical outcomes and safety will be followed throughout the study.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-02-01
• First posted: 2009-11-16
• Last updated: 2010-02-10

Locations

1 site across 1 country: Argentina