TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Efavirenz; Emtricitabine; Rilpivirine; Tenofovir

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