A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

• Must be diagnosed with HIV

• Previously randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials

• Agreed to take at least 2 antiretroviral agents from baseline onwards

• Could comply with the protocol requirements

• General medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial

Exclusion Criteria:

• A disallowed concomitant therapy

• Current or past history of active alcohol and/or drug use

• Pregnant or breast-feeding females

• Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)

• Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis

• Clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication

• Laboratory abnormalities at screening (criteria variable according to the test)