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Beverly Hills, California

  • HIV Infection

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Previous participation in the TMC114-C202 or TMC114-C213 trials - Significant virologic failure during participation in the above trials - Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening - Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards - Patient has given informed consent Exclusion Criteria: - Use of disallowed concomitant therapy - Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels - Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety - Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol - Patient withdrawing consent from TMC114-C202 or TMC114-C213


Study is Available At:


Original ID:

CR006724


NCT ID:

NCT00081588


Secondary ID:

TMC114-C215


Study Acronym:


Brief Title:

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.


Official Title:

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tibotec Pharmaceuticals, Ireland


Oversight Authority:

  • United States: Food and Drug Administration
  • Ireland: Irish Agriculture and Food Development Authority


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

555


Enrollment Type:

Actual


Overall Contact Information

Official Name:Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited

Study Dates

Start Date:November 2003
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:September 2005
Primary Completion Type:Actual
Verification Date:June 2014
Last Changed Date:June 19, 2014
First Received Date:April 15, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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 p
Time Frame:144 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:TMC114
Description:600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Arm Name:001

Study Arms

Study Arm Type:Experimental
Arm Name:001
Description:TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Tibotec Pharmaceuticals, Ireland

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:17621237

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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