TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients

This is a randomized (study drug assigned by chance), exploratory, open-label (all involved
people know the identity of the intervention) trial to evaluate the pharmacokinetics (PK),
safety, tolerability and anti-HIV (anti Human Immunodeficiency Virus) activity of etravirine
(ETR ) when given with atazanavir/ritonavir (ATV/rtv) and 1 nucleoside reverse transcriptase
inhibitor (NRTI) in 46 treatment experienced HIV-1 infected patients. The trial will consist
of : 4 weeks of Screening Period, 2 weeks Pre-Treatment Phase, 48-week Treatment Period, and
a Final Visit followed by a 4-week Follow-up Period (only for patients not continuing
treatment with ETR in another trial or program). Safety evaluations (AE reporting, labs,
vital signs, etc.) will be monitored at each study visit. A PK substudy (included in the
protocol, with optional participation) with tenofovir (TDF) added to the antiretroviral
regimen for 7 days will be conducted in patients with > 24 weeks of treatment with
suppressed HIV-1 viral load. In Pre-Treatment Phase, all patients will receive ATV/rtv
300/100 mg once daily to be taken following a meal each morning + 2 NRTIs (dose as specified
in the labels) for 14 days. In Treatment Phase, patients will receive ETR 200 mg twice
daily in addition to ATV/rtv (300/100 mg or 400/100 mg) once daily with meals + 1
investigator-selected NRTI for 48 weeks. In substudy TDF 300 mg once daily will be added to
the treatment regimen x 7 days.