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

Completed · Phase 3

Conditions studied: HIV Infections, HIV-1, Human Immunodeficiency Virus Type 1

In brief

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.

Key facts

Study ID

NCT00540449

Run by

Tibotec Pharmaceuticals, Ireland

People needed

694

Starts

2008-05-01

Expected to finish

2011-12-01

Last updated by the study team

2016-03-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Vero Beach, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Newark, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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