TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
HIV Infection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, TMC125, Non-Nucleoside reverse transcriptase inhibitor, Protease inhibitor, TMC125-C227
Eligibility Criteria
Inclusion Criteria: Male or female, age 18 years or older Documented HIV-1 infection Stable NNRTI-containing ART (minimum 12 weeks) at screening OR treatment interruption (minimum 4 weeks) at screening OR having received an NNRTI alone or in combination with other ARVs for prevention of MTCT Plasma viral load at screening above 1000 HIV-1 RNA copies/ml Prior NNRTI-experience with documented genotypic evidence of resistance to currently available NNRTIs (defined as at least one NNRTI-associated mutation per IAS-USA Drug resistance Mutation guidelines) Sensitive to the 2 NRTIs to be used as underlaying ART Subject has given informed consent Exclusion Criteria: Previous treatment with Protease Inhibitors Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection Current or past history of alcohol and/or drug use which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures Acute Hepatitis A, B or C or chronic hepatitis B or C with elevated LFTs of > 3 times ULN