TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
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ClinicalTrials.gov Identifier: NCT00110877 |
Recruitment Status
:
Completed
First Posted
: May 16, 2005
Last Update Posted
: July 3, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: LPV/rtv Drug: TMC114/rtv | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 604 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
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
|
- Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population) [ Time Frame: 48 weeks ]
- Number of Participants with Adverse Events [ Time Frame: 96 weeks ]
- Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population) [ Time Frame: 96 Weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110877

Study Director: | Tibotec Pharmaceuticals Clinical Trial | Tibotec Pharmaceutical Limited |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tibotec Pharmaceuticals, Ireland |
ClinicalTrials.gov Identifier: | NCT00110877 History of Changes |
Obsolete Identifiers: | NCT00980902 |
Other Study ID Numbers: |
CR002794 TMC114-C214 ( Other Identifier: Tibotec Pharmaceuticals, Ireland ) |
First Posted: | May 16, 2005 Key Record Dates |
Last Update Posted: | July 3, 2015 |
Last Verified: | July 2015 |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
Human Immunodeficiency Virus Treatment Experienced TMC114-C214 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |