TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
HIV Infection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Human Immunodeficiency Virus, Treatment Experienced, TMC114-C214
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
002
001
LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV