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

This study has been completed.
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland Identifier:
First received: May 13, 2005
Last updated: July 1, 2015
Last verified: July 2015
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.

Condition Intervention Phase
HIV Infection
Drug: LPV/rtv
Drug: TMC114/rtv
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population) [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: April 2005
Study Completion Date: October 2011
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 002
LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
Drug: LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
Experimental: 001
TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV
Drug: TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00110877

  Show 107 Study Locations
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT00110877     History of Changes
Obsolete Identifiers: NCT00980902
Other Study ID Numbers: CR002794  TMC114-C214 
Study First Received: May 13, 2005
Last Updated: July 1, 2015
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Great Britain: Medicines and Healthcare Products Regulatory Agency
Great Britain: Research Ethics Committee

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Human Immunodeficiency Virus
Treatment Experienced

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors processed this record on May 25, 2016