TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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-naïve treatment-experienced HIV-1 infected patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Darunavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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