Status:
COMPLETED
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected parti...
Detailed Description
This was a phase II, open label, multicenter trial of an investigational protease inhibitor TMC114 in the presence of ritonavir (rtv) in HIV-1 infected participants who were randomized in trials TMC11...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Must be diagnosed with HIV
- Previously randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials
- Agreed to take at least 2 antiretroviral agents from baseline onwards
- Could comply with the protocol requirements
- General medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial
- Exclusion Criteria:
- A disallowed concomitant therapy
- Current or past history of active alcohol and/or drug use
- Pregnant or breast-feeding females
- Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)
- Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis
- Clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication
- Laboratory abnormalities at screening (criteria variable according to the test)
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02187107
Start Date
January 1 2005
End Date
March 1 2009
Last Update
August 25 2014
Active Locations (11)
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1
Darlinghurst, Australia
2
Vienna, Austria
3
Ghent, Belgium
4
Copenhagen, Denmark