TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
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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 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 |
- Change in viral load at 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Evaluate safety, tolerability and durability of efficacy over 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
| 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.
Eligibility| 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
Show 107 Study Locations| Study Director: | Tibotec Pharmaceuticals Clinical Trial | Tibotec Pharmaceutical Limited |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Compound Development Team Leader TMC114, Tibotec Pharmaceutical Limited |
| ClinicalTrials.gov Identifier: | NCT00110877 History of Changes |
| Obsolete Identifiers: | NCT00980902 |
| Other Study ID Numbers: | CR002794, TMC114-C214 |
| Study First Received: | May 13, 2005 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority Great Britain: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
|
Human Immunodeficiency Virus Treatment Experienced TMC114-C214 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013