An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
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Tracking Information | |||||
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First Received Date ICMJE | April 15, 2004 | ||||
Last Updated Date | June 2, 2011 | ||||
Start Date ICMJE | November 2003 | ||||
Primary Completion Date | September 2005 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Viral Load | ||||
Change History | Complete list of historical versions of study NCT00081588 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points [ Time Frame: 144 weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Evaluation of antiviral activity, immunologic effects over time. [ Time Frame: At all times ] [ Designated as safety issue: No ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects. | ||||
Official Title ICMJE | An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects. | ||||
Brief Summary | The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time. |
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Detailed Description | The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | HIV Infection | ||||
Intervention ICMJE | Drug: TMC114
600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available |
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Study Arm (s) | Experimental: 001
TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Intervention: Drug: TMC114 |
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Publications * | Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 555 | ||||
Completion Date | December 2008 | ||||
Primary Completion Date | September 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00081588 | ||||
Other Study ID Numbers ICMJE | CR006724, TMC114-C215 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Compound Development Team Leader TMC114, Tibotec Pharmaceutical Limited | ||||
Study Sponsor ICMJE | Tibotec Pharmaceuticals, Ireland | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Tibotec Pharmaceuticals, Ireland | ||||
Verification Date | June 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |