Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

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

Summary

The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.

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

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Patients with documented HIV-1 infection

• Patients currently receiving HAART for at least 24 weeks

• Plasma viral load < 50 copies/mL for at least 24 weeks prior to screening (two results must be documented)

• Patients taking the same antiretroviral combination for at least 8 weeks before screening

• Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity

• CD4 > 100/mm3 at the start of HAART and > 200/mm3 at screening.

Exclusion Criteria:

• No history of virological failure defined as two consecutive plasma HIV-1 RNA > 500 copies/mL while on previous or current antiretroviral therapy

• No history of any primary PI mutations as defined by the IAS-USA guidelines 2006

• No patients co-infected with hepatitis B

• No pregnant or breastfeeding women

• No active clinically significant disease or life threatening disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study.