NCT02187107

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

An Open Label Trial of TMC114/Rtv in HIV-1 Infected Subjects Who Were Randomized in the Trials TMC114-C201, TMC114-C207 or in Sponsor Selected Phase I Trials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a phase II, open label, multicenter trial of an investigational protease inhibitor TMC114 in the presence of ritonavir (rtv) in HIV-1 infected participants who were randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected phase I trials and who might derive benefit from TMC114 therapy, as judged by the investigator. The trial consisted of a screening period of a maximum of 4 weeks, a 96-week treatment period and a 4-week follow-up period. The maximal trial duration for each participant was104 weeks. During the treatment period, all participants were receiving TMC114 in combination with RTV, orally, as 600/100 mg dose twice daily, in addition to an individually optimized background regimen of antiretroviral (ARV) therapy, selected by the investigator at a baseline of the study. Sponsor provided a follow-up treatment with TMC114 for all participants who continued to benefit from treatment with TMC114/RTV until it became commercially available for the participant. Participants, who completed the 96 weeks of treatment period with TMC114, had the opportunity to roll over to the extension of this trial, if TMC114 was not locally commercially available.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	TMC114	300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange
DRUG	rtv	100 mg tablet of Norvir®

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-09-01
• Completion: 2009-03-01
• First posted: 2014-07-10
• Last updated: 2014-08-25

Locations

11 sites across 8 countries: Australia, Austria, Belgium, Denmark, Germany, Poland, Russia, United Kingdom