A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patie

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never received ARV treatment).

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

Details

• Lead Sponsor: Tibotec, Inc
• Collaborator: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: Darunavir; Emtricitabine; Etravirine; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Documented HIV-1 infection

• Naive to antiretroviral therapy (never received antiretroviral therapy prior to study)

• In the opinion of the investigator, have an indication for antiretroviral therapy

• Able to comply with the protocol requirements

Exclusion Criteria:

• No previous or current use of antiretroviral medications (ARVs) for the treatment of HIV infection or hepatitis B/C infection with anti-HIV activity

• No evidence of antiretroviral resistance on current or past resistance assays

• No chronic hepatitis B and/or C co-infection

• No grade 3 or 4 laboratory abnormality as defined by National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) grading tables, or a calculated creatinine clearance (CLCr) < 50 mL/min.

• No known diabetes mellitus or hyperlipidemia requiring lipid-lowering therapy

• No acute viral hepatitis including, but not limited to A, B, or C.