A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.

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

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Efavirenz; Etravirine; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• Documented HIV-1 infection

• In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the patients medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection

• Patient has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection

• HIV-1 plasma viral load at screening >= 5000 HIV-1 RNA (copies/ml)

• Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs in their background regimen at screening

Exclusion Criteria:

• Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission

• The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance

• Known infection with HIV-2 or with HIV-1 group O

• Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if not progressive

• Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured

• Specific grade 3 or 4 laboratory abnormalities