TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00110877
First received: May 13, 2005
Last updated: June 12, 2012
Last verified: June 2012

May 13, 2005
June 12, 2012
April 2005
January 2007   (final data collection date for primary outcome measure)
Change in viral load at 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Change in viral load at 48 weeks.
Complete list of historical versions of study NCT00110877 on ClinicalTrials.gov Archive Site
Evaluate safety, tolerability and durability of efficacy over 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Evaluate safety, tolerability and durability of efficacy over 96 weeks.
Not Provided
Not Provided
 
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
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

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.

Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: LPV/rtv
    One 400mg LPV tablet twice daily with 100mg RTV
  • Drug: TMC114/rtv
    Two 300mg TMC114 tablets twice daily with 100mg RTV
  • Experimental: 002
    LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
    Intervention: Drug: LPV/rtv
  • Experimental: 001
    TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV
    Intervention: Drug: TMC114/rtv

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
604
October 2011
January 2007   (final data collection date for primary outcome measure)

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

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Denmark,   France,   Germany,   Greece,   Guatemala,   Hungary,   Malaysia,   Mexico,   Netherlands,   Panama,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Switzerland,   Thailand
 
NCT00110877
CR002794, TMC114-C214
Yes
Compound Development Team Leader TMC114, Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP