Status:
COMPLETED
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-n...
Detailed Description
Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability o...
Eligibility Criteria
Inclusion
- Patient has documented HIV-1 infection
- Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
- Plasma HIV-1 RNA \>1000 copies/mL
- General medical condition does not interfere with the assessments and the completion of the trial
Exclusion
- Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
- tenofovir, emtricitabine, atazanavir, fosamprenavir
- Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
- Life expectancy of less than 6 months
- Pregnant or breast-feeding
- Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
- Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
- Participation in other investigational trials without prior approval of the sponsor
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT00110877
Start Date
April 1 2005
End Date
October 1 2011
Last Update
July 3 2015
Active Locations (103)
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Phoenix, Arizona, United States
2
Little Rock, Arkansas, United States
3
Beverly Hills, California, United States
4
Long Beach, California, United States