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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/NCT00110877




Registration number
NCT00110877
Ethics application status
Date submitted
13/05/2005
Date registered
16/05/2005
Date last updated
3/07/2015

Titles & IDs
Public title
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
Scientific title
A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients
Secondary ID [1] 0 0
TMC114-C214
Secondary ID [2] 0 0
CR002794
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

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

Experimental: 002 - LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV

Experimental: 001 - TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV


Treatment: Drugs: LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV

Treatment: Drugs: TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Number of Participants with Adverse Events
Timepoint [1] 0 0
96 weeks
Secondary outcome [2] 0 0
Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
Timepoint [2] 0 0
96 Weeks

Eligibility
Key inclusion criteria
- Patient has documented HIV-1 infection

- Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination
with at least 1 NNRTI and/or 1 PI) for at least 12 weeks

- Plasma HIV-1 RNA >1000 copies/mL

- General medical condition does not interfere with the assessments and the completion
of the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients for whom an investigational Antiretroviral is part of the current regimen,
with the following exceptions if applicable (depending on local regulatory approval)

- tenofovir, emtricitabine, atazanavir, fosamprenavir

- Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114

- Life expectancy of less than 6 months

- Pregnant or breast-feeding

- Females of childbearing potential not willing to use effective non-hormonal birth
control methods or not willing to continue practicing these birth control methods for
at least 14 days after the end of the treatment period

- Patients with significantly decreased liver function or decompensation, irrespective
of liver enzyme levels

- Participation in other investigational trials without prior approval of the sponsor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
604
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Perth
Recruitment hospital [4] 0 0
- Surry Hills
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Surry Hills
Recruitment outside Australia
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Arizona
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California
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Rosario
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Austria
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Wien N/A
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Austria
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Wien
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Belgium
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Antwerpen
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Brussels
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Curitiba
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Nova Iguacu
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Pinheiros
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Chile
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Aalborg
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Rennes
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Mexico
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Groningen
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Lisboa
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Porto
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Puerto Rico
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San Juan
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Russian Federation
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Kazan
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Russian Federation
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Moscow N/A
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Russian Federation
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Nizhny Novgorod
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Saint-Petersburg
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St Petersburg
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Russian Federation
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Volgograd
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Houghton, Johannesburg
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Johannesburg
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South Africa
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Pretoria
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Spain
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Barcelona
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Madrid
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Switzerland
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Zurich N/A
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy,
safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra
(LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00110877
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec Pharmaceuticals Clinical Trial
Address 0 0
Tibotec Pharmaceutical Limited
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/NCT00110877