Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

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

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Tibotec Pharmaceutical Limited
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Confirmed HIV-1 infection.

• Documented level of HIV-1 RNA at initiation of antiretroviral treatments

• Prior antiretroviral regimen, including at least 2 NRTIs combined to 1 PI or NNRTI or a third NRTI for at least 18 months prior to study entry.

• CD4 count of 200 cells per mm3 or greater.

• Viral load below 400 copies per ml within 18 months prior to entry and below 50 copies per mL at entry.

• Willing to use acceptable methods of contraception

Exclusion Criteria:

• Previous virological failure under prior PI-based regimen.

• Prior therapy in the darunavir.

• HIV-2 infected patients.

• Absence of documented level of HIV-1 RNA at initiation of antiretroviral treatments

• Hepatitis B or C infection within 90 days prior to study entry.

• Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.

• Serious acute illness requiring systemic treatment or hospitalization in the 14 days prior to study entry.

• Treatment for an active AIDS defining opportunistic infection within 30 days prior to screening

• Drug or alcohol use or any dependence that would interfere with compliance.

• Pregnancy or breastfeeding