Phase 3
N=678
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
HIV Infections · HIV-1
Bottom Line
View on ClinicalTrials.gov: NCT00543725 ↗Enrolled (actual)
678
Serious AEs
9.3%
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 Per mL) at Week 48 — 291; 276; 24; 18 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
- Jan 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 Per mL) at Week 48 |
291; 276; 24; 18; 1; 3 | <0.0001 sig |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48 |
281; 265; 41; 38; 18; 35 | <0.0001 sig |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96 |
269; 258; 34; 24; 1; 3 | <0.0001 sig |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96 |
259; 254; 53; 38; 28; 46 | <0.0001 sig |
| SECONDARY Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96). |
260; 246 | — |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48 |
300; 286 | — |
| SECONDARY Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96 |
283; 270 | — |
| SECONDARY Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data) |
188.6; 170.7; 234.5; 212.0; 8.3; 8.0 | — |
| SECONDARY Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure |
17; 11; 13; 1; 3; 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 background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) 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 and 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 the 2 nucleoside/nucleotide reverse transcriptase inhibitors chosen for treatment
- Patient agrees not to start ART before the baseline visit
- Patient is HLA-B*5701 negative in case abacavir is included in the patient's treatment regimen.
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 (NCT00543725). 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.