An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
Recruiting in Palo Alto (17 mi)
+67 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Tibotec Pharmaceuticals, Ireland
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
Research Team
TP
Tibotec Pharmaceuticals Clinical Trial
Principal Investigator
Tibotec Pharmaceutical Limited
Eligibility Criteria
Inclusion Criteria
Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
Previous participation in the TMC114-C202 or TMC114-C213 trials
Significant virologic failure during participation in the above trials
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Treatment Details
Interventions
- TMC114 (Protease Inhibitor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 001Experimental Treatment1 Intervention
TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tibotec Pharmaceuticals, Ireland
Lead Sponsor
Trials
77
Recruited
15,700+
Paul Stoffels
Tibotec Pharmaceuticals, Ireland
Chief Executive Officer since 2021
PhD in Microbiology from Miami University
Craig Tendler
Tibotec Pharmaceuticals, Ireland
Chief Medical Officer since 2015
MD from Mount Sinai School of Medicine