At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection documented
- ✓Antiretroviral-naive or minimal prior treatment (≤2 weeks of NRTIs)
- ✓HIV-1 viral load >5000 RNA copies/mL at screening
- ✓Sensitivity to investigator-selected nucleosides at screening
- ✕Active AIDS-defining illness
- ✕Acute (primary) HIV-1 infection
- ✕History or current adrenal disorder
- ✕Acute hepatitis A, B, or C infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIb Randomized, Partially Blinded, Dose-Finding Trial of TMC278 in Antiretroviral-Naive HIV-1 Infected Subjects
In Brief
A Phase 2 clinical trial evaluating TMC278 25 mg, TMC278 75 mg, and 3 other interventions for Human Immunodeficiency Virus Type 1. Completed, enrolled 368 participants across 40 sites in 14 countries.
Detailed Summary
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
Study Details
Timeline
Interventions
TMC278 25 mg tablet will be administered once daily.
TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily.
TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily.
Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily.
Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period.