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

Tibotec Pharmaceuticals, Ireland52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

TMC114DRUG

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

rtvDRUG

100 mg tablet of Norvir®

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (11)

Unnamed facility

Darlinghurst, Australia

Unnamed facility

Vienna, Austria

Unnamed facility

Ghent, Belgium

Unnamed facility

Copenhagen, Denmark

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.

Time frame: Week 48, Week 96

Change in CD4 cells absolute count

The immunologic change will be determined by changes in absolute values for CD4 cells.

Time frame: Week 48, Week 96

Data from ClinicalTrials.gov

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