NCT00543725
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
Sponsored by Tibotec Pharmaceuticals, Ireland
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.
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
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Atlantis, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Newark, New Jersey, United States
Flushing, New York, United States
New York, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Darlinghurst, Australia
Prahran, Australia
Surry Hills, Australia
Antwerp, Belgium
Brussels, Belgium
Ghent, Belgium
Leuven, Belgium
Campinas, Brazil
Distrito Barao Geraldo-Campina, Brazil
Pinheiros, Brazil
Recife, Brazil
São Paulo, Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Providencia, Chile
Santiago, Chile
Beijing, China
Guangzhou, China
Shanghai, China
San José, Costa Rica
Clamart, France
Le Kremlin-Bicêtre, France
Montpellier, France
Paris, France
Berlin, Germany
Cologne, Germany
Essen, Germany
Frankfurt, Germany
Hamburg, Germany
Hanover, Germany
Mannheim, Germany
Chennai, India
Nagpur, India
Guadalajara, Mexico
Mexico City, Mexico
Panama City, Panama
Porto, Portugal
San Juan, Puerto Rico
Moscow, Russia
Saint Petersburg, Russia
Smolensk, Russia
Voronezh, Russia
Bloemfontein, South Africa
Cape Town, South Africa
Dundee, South Africa
Johannesburg, South Africa
Pretoria, South Africa
Westdene Johannesburg Gauteng, South Africa
Barcelona, Spain
Elche, Spain
Madrid, Spain
Bangkok, Thailand
London, United Kingdom
Manchester, United Kingdom
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
Interested in this trial?
Express your interest and we'll connect you with the trial team.
Your selected profile and contact information may be shared with an authorised trial site, sponsor, or Clintriva coordination team for trial contact and pre-screening. Expressing interest does not mean you are eligible or enrolled.
Conditions