A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.

• CD4 count ≥100 cells/mm3 at Screening.

• Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.

Exclusion Criteria:

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

• Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.

• X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.