Clinical trial NCT02187107: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: HIV
AIDS
TMC114
Ritonavir
Norvir
Darunavir
Lead sponsor: Tibotec Pharmaceuticals, Ireland
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
timeFrame: Baseline, up to the end of follow-up period (approximatelly 100 weeks)
Secondary outcomes:
measure: Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)
timeFrame: Week 48, Week 96
measure: Change in CD4 cells absolute count
timeFrame: Week 48, Week 96
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
city: Wien
country: Austria
city: Gent
country: Belgium
city: Copenhagen
country: Denmark
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Munich
country: Germany
city: Szczecin
country: Poland
city: Sint Petersburg
country: Russian Federation
city: London
country: United Kingdom
Study officials:
affiliation: Tibotec Pharmaceuticals, Ireland
name: Tibotec Pharmaceuticals Limited, Ireland Clinical Trial
role: STUDY_DIRECTOR
References: