Overview

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