TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients

Completed · Phase 2

Conditions studied: HIV Infections, Acquired Immunodeficiency Syndrome

In brief

The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.

Key facts

Study ID

NCT00896051

Run by

Janssen R&D Ireland

People needed

50

Starts

2009-08-01

Expected to finish

2012-04-01

Last updated by the study team

2013-09-30

Who can join

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

You may qualify if…

• Documented HIV-1 infection
• Failing on a stable ART (anti retroviral therapy) with HIV-1 plasma viral load above 500 HIV-1 RNA copies/ml
• Presence of at least 1 documented NNRTI mutation
• Demonstrated sensitivity to ATV, ETR and at least one of the selected NRTIs based on the resistance test at screening
• General medical condition, in the investigator's opinion, does not interfere with the assessments and completion of the trial
• Substudy: patients who have been treated in C238 for more than 24 weeks and are currently suppressed (defined as patients with at least 2 most recent and consecutive viral loads less than 50 cp/mL) will be considered eligible for the substudy

You may not qualify if…

• Primary HIV-1 infection
• Previously documented HIV-2 infection
• Previously failed 2 or more HIV PI-containing regimens
• Previous diagnosis of hereditary hyperbilirubinemia (eg. Gilbert's syndrome, Crigler-Najjar syndrome).
• Grade 3 or 4 toxicities (according to DAIDS grading)
• Acute and chronic viral hepatitis
• Receipt of an investigational drug or investigational vaccine within 30 days prior to the trial drug administration
• Pregnant or breastfeeding female

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Paris, France
• Study site — Tourcoing, France
• Study site — Bloemfontein, South Africa
• Study site — Cape Town, South Africa
• Study site — George, South Africa
• Study site — Bangkok, Thailand

Full record on ClinicalTrials.gov

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