Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The main study is a single arm, open-label, prospective study to assess antiretroviral
activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose
tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a
genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of
the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in
genital secretions when subjects are taking etravirine. The purpose of the metabolic
sub-study is to learn about the effects of etravirine on body composition, as well as lipid
and glucose levels.
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Janssen Pharmaceuticals
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Etravirine Tenofovir