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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT02187107
First received: February 25, 2014
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
HIV
Drug: TMC114
Drug: rtv
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 52
Study Start Date: January 2005
Study Completion Date: March 2009
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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®
Other Name: Norvir

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02187107

Locations
Australia
Darlinghurst, Australia
Austria
Wien, Austria
Belgium
Gent, Belgium
Denmark
Copenhagen, Denmark
Germany
Berlin, Germany
Hamburg, Germany
Hannover, Germany
Munich, Germany
Poland
Szczecin, Poland
Russian Federation
Sint Petersburg, Russian Federation
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Limited, Ireland Clinical Trial Tibotec Pharmaceuticals, Ireland
  More Information

No publications provided

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT02187107     History of Changes
Other Study ID Numbers: CR005848, TMC114-C208
Study First Received: February 25, 2014
Last Updated: July 7, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Department of Health

Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV
AIDS
TMC114
Ritonavir
Norvir
Darunavir

Additional relevant MeSH terms:
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014