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

NCT ID: NCT00081588

Last Updated: 2014-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-12-31

Brief Summary

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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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TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

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TMC114-C213: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.

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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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001

TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Group Type EXPERIMENTAL

TMC114

Intervention Type DRUG

600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Interventions

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TMC114

600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tibotec Pharmaceuticals Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceutical Limited

Locations

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Birmingham, Alabama, United States

Site Status

Beverly Hills, California, United States

Site Status

La Jolla, California, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Oakland, California, United States

Site Status

San Francisco, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Vero Beach, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Macon, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Springfield, Massachusetts, United States

Site Status

Camden, New Jersey, United States

Site Status

Albany, New York, United States

Site Status

New York, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Dallas, Texas, United States

Site Status

Galveston, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

Site Status

Buenos Aires, , Argentina

Site Status

Darlinghurst, , Australia

Site Status

Melbourne, , Australia

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Perth, , Australia

Site Status

Vienna, , Austria

Site Status

Brussels, , Belgium

Site Status

Ghent, , Belgium

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Campinas, , Brazil

Site Status

Curitiba, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Calgary, Alberta, Canada

Site Status

Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Le Kremlin-Bicêtre, , France

Site Status

Montpellier, , France

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Nantes, , France

Site Status

Paris, , France

Site Status

Toulon, , France

Site Status

Villejuif, , France

Site Status

Berlin, , Germany

Site Status

Bonn, , Germany

Site Status

Düsseldorf, , Germany

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Essen, , Germany

Site Status

Freiburg im Breisgau, , Germany

Site Status

Hamburg, , Germany

Site Status

Kÿln, , Germany

Site Status

Mannheim, , Germany

Site Status

Munich, , Germany

Site Status

Budapest, , Hungary

Site Status

Lisbon, , Portugal

Site Status

Porto, , Portugal

Site Status

Barakaldo Vizcaya S/N, , Spain

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Edinburgh, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada France Germany Hungary Portugal Spain United Kingdom

References

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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. doi: 10.1097/QAI.0b013e3181359cfb.

Reference Type RESULT
PMID: 17621237 (View on PubMed)

Other Identifiers

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TMC114-C215

Identifier Type: -

Identifier Source: secondary_id

CR006724

Identifier Type: -

Identifier Source: org_study_id

NCT00980226

Identifier Type: -

Identifier Source: nct_alias

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