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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187107
• Other study ID #: CR005848
• Secondary ID: TMC114-C208
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2014
• Last updated: August 22, 2014
• Start date: January 2005
• Est. completion date: March 2009

Study information

• Verified date: August 2014
• Source: Tibotec Pharmaceuticals, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2009
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• TMC114
300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange
• rtv
100 mg tablet of Norvir®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tibotec Pharmaceuticals, Ireland

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  Germany,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination		Baseline, up to the end of follow-up period (approximatelly 100 weeks)	Yes
Secondary	Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)	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.	Week 48, Week 96	No
Secondary	Change in CD4 cells absolute count	The immunologic change will be determined by changes in absolute values for CD4 cells.	Week 48, Week 96	No

External Links

•   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