Status:
COMPLETED
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have...
Detailed Description
This is a randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r) versus lpv/rtv in treatment-naive HIV-1 infected patients. Six hundred si...
Eligibility Criteria
Inclusion
- Patients with documented HIV-1 infection
- Screening plasma HIV-1 RNA \>= 5000 copies/mL
- Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines
- Patients who can comply with the protocol requirements
- General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Exclusion
- Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection
- Life expectancy of less than 6 months
- Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity
- Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
- -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) \< 70 mL/min
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT00258557
Start Date
September 1 2005
End Date
May 1 2012
Last Update
June 26 2013
Active Locations (89)
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Phoenix, Arizona, United States
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Beverly Hills, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States