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

Sponsored by:	Tibotec Pharmaceutical Limited
Information provided by:	Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier:	NCT00110877

Purpose

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Tibotec Pharmaceutical Limited:

Primary Outcome Measures:

Change in viral load at 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety, tolerability and durability of efficacy over 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV
002: Experimental	Drug: LPV/rtv One 400mg LPV tablet 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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110877

Sponsors and Collaborators

Tibotec Pharmaceutical Limited

Investigators

Study Director:

Tibotec Clinical Trial

Tibotec Pharmaceutical Limited

More Information

Publications of Results:

Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58.

Responsible Party:	Tibotec Pharmaceutical Limited ( Compound Development Team Leader TMC114 )
Study ID Numbers:	CR002794, TMC114-C214
Study First Received:	May 13, 2005
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00110877
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tibotec Pharmaceutical Limited:

Human Immunodeficiency Virus
Treatment Experienced
TMC114-C214

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Darunavir
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009