A Phase III, randomized, double-blind study of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects.
Phase 3
Completed
- Conditions
- HIV-1 infection - AIDS10021460
- Registration Number
- NL-OMON32184
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Male or female subjects, aged 18 years or older;
Subject with documented HIV-1 infection;
Subject has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening;
HIV-1 plasma viral load at screening is >= 5,000 HIV-1 RNA copies/mL
Exclusion Criteria
Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission;
Having documented genotypic evidence of NNRTI resistance at screening;
Previously documented HIV-2 infection;
Subject has any currently active AIDS defining illness (with a few exceptions).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the trial is to demonstrate non-inferiority of<br /><br>treatment with TMC278 when administered as 75 mg q.d. compared to the control<br /><br>group (EFV) in regard to the proportion of virologic responders (plasma viral<br /><br>load < 50 HIV-1 RNA copies/mL, according to TLOVR algorithm) at 48 weeks in<br /><br>ARV-naïve HIV-infected subjects, with a maximum<br /><br>allowable difference of 12%.</p><br>
- Secondary Outcome Measures
Name Time Method