TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, TMC114, Ritonavir, Tolerability, Safety and efficacy, TMC114-C211
Eligibility Criteria
Inclusion Criteria: Male or female, age 18 years or older Documented HIV-1 infection Stable PI regimen for at least 8 weeks prior to screening Plasma viral load at screening above 1000 HIV-1 RNA copies/ml Prior use of more than 1 NRTI for at least 3 months Prior use of one or more NNRTIs as part of a failing regimen At least 1 primary PI mutation as defined by the IAS guidelines Treatment with at least 1 PI for a total of at least 3 months Patient has given informed consent Exclusion Criteria: Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures NNRTI as part of therapy at screening Patients on a treatment interruption at screening Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening Hepatitis A, B, or C.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
No Intervention
Experimental
Experimental
Experimental
001
005
004
003
002
TMC114/rtv 400mg TMC114/100mg rtv once daily
Control Group Control Group, no intervention
TMC114/rtv 600mg TMC114/100mg rtv twice daily
TMC114/rtv 400mg TMC114/100mg rtv both twice daily
TMC114/rtv 800mg TMC114/100mg rtv once daily