Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Darunavir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.

• CD4 count equal to or greater than 100 cells/mm3 at Screening.

• Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.

Exclusion Criteria:

• Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.

• Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.

• CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.