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 Exper

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Atazanavir Sulfate; Etravirine; Reverse Transcriptase Inhibitors; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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