Status:
COMPLETED
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)...
Detailed Description
Patients who have previously received a first HIV NNRTI containing regimen or who have received an NNRTI containing treatment for prevention of mother to child transmission (MTCT), and who have never ...
Eligibility Criteria
Inclusion
- Male or female, age 18 years or older
- Documented HIV-1 infection
- Stable NNRTI-containing ART (minimum 12 weeks) at screening OR treatment interruption (minimum 4 weeks) at screening OR having received an NNRTI alone or in combination with other ARVs for prevention of MTCT
- Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
- Prior NNRTI-experience with documented genotypic evidence of resistance to currently available NNRTIs (defined as at least one NNRTI-associated mutation per IAS-USA Drug resistance Mutation guidelines)
- Sensitive to the 2 NRTIs to be used as underlaying ART
- Subject has given informed consent
Exclusion
- Previous treatment with Protease Inhibitors
- Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
- Current or past history of alcohol and/or drug use which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
- Acute Hepatitis A, B or C or chronic hepatitis B or C with elevated LFTs of \> 3 times ULN
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00225303
Start Date
March 1 2005
End Date
June 1 2006
Last Update
May 19 2011
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