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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02187107




Registration number
NCT02187107
Ethics application status
Date submitted
25/02/2014
Date registered
10/07/2014
Date last updated
25/08/2014

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
TMC114-C208
Secondary ID [2] 0 0
CR005848
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TMC114
Treatment: Drugs - rtv

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


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

Treatment: Drugs: rtv
100 mg tablet of Norvir®
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
Timepoint [1] 0 0
Baseline, up to the end of follow-up period (approximatelly 100 weeks)
Secondary outcome [1] 0 0
Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)
Timepoint [1] 0 0
Week 48, Week 96
Secondary outcome [2] 0 0
Change in CD4 cells absolute count
Timepoint [2] 0 0
Week 48, Week 96

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Denmark
State/province [3] 0 0
Copenhagen
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Hamburg
Country [6] 0 0
Germany
State/province [6] 0 0
Hannover
Country [7] 0 0
Germany
State/province [7] 0 0
Munich
Country [8] 0 0
Poland
State/province [8] 0 0
Szczecin
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Sint Petersburg
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tibotec Pharmaceuticals, Ireland
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02187107
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec Pharmaceuticals Limited, Ireland Clinical Trial
Address 0 0
Tibotec Pharmaceuticals, Ireland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02187107