Phase 3
N=690
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
HIV Infections · HIV-1 · Human Immunodeficiency Virus Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00540449 ↗Enrolled (actual)
690
Serious AEs
12.0%
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 — 287; 285; 38; 15 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TMC278 (Drug); Efavirenz (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tibotec Pharmaceuticals, Ireland
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 |
287; 285; 38; 15; 6; 25 | <0.0001 sig |
| SECONDARY The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48 |
285; 281; 47; 24; 14; 39 | <0.0001 sig |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96 |
263; 271; 45; 16; 0; 3 | 0.0055 sig |
| SECONDARY The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96 |
265; 268; 54; 27; 27; 49 | 0.0013 sig |
| SECONDARY Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96). |
245; 261 | — |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48 |
297; 293 | — |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96 |
273; 278 | — |
| SECONDARY Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) |
195.5; 181.6; 220.7; 226.7; 8.6; 8.7 | — |
| SECONDARY Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure |
29; 9; 18; 0; 5; 0 | — |
Summary
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.
Eligibility Criteria
Inclusion Criteria
- Patient with documented HIV-1 infection
- Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
- Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
- Patient's virus is sensitive to TDF and FTC
- Patient agrees not to start ART (antiretroviral treatment) before the baseline visit
Exclusion Criteria
- Previous use of ANY ARV drug for ANY length of time
- Any documented evidence of NNRTI resistance associated mutations in patient's HIV
- Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if not progressive
- Pneumocystis carinii pneumonia (PCP) that is considered not cured
- Active TB
- Allergy or hypersensitivity to study or background ARTs
- Specific grade 3 or 4 toxicity
- Kidney impairment: calculated creatinine clearance <50 ml/min
Data sourced from ClinicalTrials.gov (NCT00540449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.