Status:
COMPLETED
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
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
HIV Infection
HIV
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 1...
Detailed Description
This is a phase IIb, randomised (study medication is assigned by chance), double-blind (neither the patient nor the study physician will know to which treatment group the patient is assigned) trial to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00903682
Start Date
June 1 2009
End Date
January 1 2011
Last Update
January 14 2013
Active Locations (33)
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1
Salzburg, Austria
2
Vienna, Austria
3
Aarhus, Denmark
4
Odense, Denmark