A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines

Completed · Phase 2

Conditions studied: Human Immunodeficiency Virus Type 1

In brief

The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

Key facts

Study ID

NCT00110305

Run by

Tibotec Pharmaceuticals, Ireland

People needed

368

Starts

2005-06-01

Expected to finish

2011-12-01

Last updated by the study team

2014-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented human immunodeficiency virus type 1 (HIV-1) infection
• Never been treated with an antiretroviral (ARV) treatment or therapeutic HIV vaccine, or received less than or equal to 2 weeks treatment prior to screening with an nucleoside reverse transcriptase inhibitors
• HIV-1 plasma viral load above 5000 HIV-1 RNA copies per milliliter, at screening
• Cortisol of at least 550 nano moles per liter (19.9 microgram per deciliter) at screening
• Sensitivity to investigator selected nucleosides, at screening

You may not qualify if…

• Currently having active Acquired Immunodeficiency Syndrome (AIDS) defining illness
• Known or suspected acute (primary) HIV-1 infection
• Any current or history of adrenal disorder, and an acute hepatitis A, B, or C infection
• Documented genotypic evidence of Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) resistance at screening
• Pregnant or breastfeeding females
• Not agree to protocol-defined effective use of contraception

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Stony Brook, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Addison, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Argentina
• Study site — Vienna, Austria
• Study site — Campinas, Brazil
• Study site — Curitiba, Brazil
• Study site — Pinheiros, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — São Paulo, Brazil
• Study site — Beijing, China
• Study site — Paris, France
• Study site — Tourcoing, France
• Study site — Berlin, Germany
• Study site — Cologne, Germany
• Study site — Freiburg im Breisgau, Germany
• Study site — München, Germany
• Study site — Mexico City, Mexico

Full record on ClinicalTrials.gov

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