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

NCT ID: NCT02187107

Last Updated: 2014-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TMC114

Intervention Type: DRUG

300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange

rtv

Intervention Type: DRUG

100 mg tablet of Norvir®

Interventions

TMC114

300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange

Intervention Type: DRUG

rtv

100 mg tablet of Norvir®

Intervention Type: DRUG

Other Intervention Names

Norvir

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibotec Pharmaceuticals Limited, Ireland Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceuticals, Ireland

Locations

Darlinghurst, , Australia

Vienna, , Austria

Ghent, , Belgium

Copenhagen, , Denmark

Berlin, , Germany

Hamburg, , Germany

Hanover, , Germany

Munich, , Germany

Szczecin, , Poland

Saint Petersburg, , Russia

London, , United Kingdom

Countries

Australia; Austria; Belgium; Denmark; Germany; Poland; Russia; United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1455&filename=CR005848_CSR.pdf

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

Other Identifiers

TMC114-C208

Identifier Type: OTHER

Identifier Source: secondary_id

CR005848

Identifier Type: -

Identifier Source: org_study_id