Status:
COMPLETED
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
Lead Sponsor:
Janssen R&D Ireland
Conditions:
HIV Infections
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 experi...
Detailed Description
This is a randomized (study drug assigned by chance), exploratory, open-label (all involved people know the identity of the intervention) trial to evaluate the pharmacokinetics (PK), safety, tolerabil...
Eligibility Criteria
Inclusion
- \- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00896051
Start Date
August 1 2009
End Date
April 1 2012
Last Update
September 30 2013
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Little Rock, Arkansas, United States
2
Bakersfield, California, United States
3
Beverly Hills, California, United States
4
Orlando, Florida, United States