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
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination [ Time Frame: Baseline, up to the end of follow-up period (approximatelly 100 weeks) ] [ Designated as safety issue: Yes ]
- Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored) [ Time Frame: Week 48, Week 96 ] [ Designated as safety issue: No ]The Time to Loss of Virologic Response (TLOVR) algorithm will be used to derive response. Response will be confirmed at 2 consecutive visits and participants who discontinue will be considered nonresponders after discontinuation. Resuppression after confirmed virologic failure will be considered as failure. Virologic Failure will include participants who are rebounders (ie, confirmed viral load >= 50 copies/mL after being a responder) or who were never suppressed (no confirmed viral load <50 copies/mL); non-VF censored: participants who discontinue treatment due to reason other than Virologic Failure will be excluded.
- Change in CD4 cells absolute count [ Time Frame: Week 48, Week 96 ] [ Designated as safety issue: No ]The immunologic change will be determined by changes in absolute values for CD4 cells.
|Study Start Date:||January 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Experimental: TMC114 + rtv
Every participant recieves 2 tablets of TMC114, 300 mg, combined with one tablet of rtv (ritonavir), 100mg, orally twice daily, every 12 hours
300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® OrangeDrug: rtv
100 mg tablet of Norvir®
Other Name: Norvir
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02187107
|Sint Petersburg, Russian Federation|
|London, United Kingdom|
|Study Director:||Tibotec Pharmaceuticals Limited, Ireland Clinical Trial||Tibotec Pharmaceuticals, Ireland|