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

Tracking Information

First Received Date ^ICMJE

April 15, 2004

Last Updated Date

October 2, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

February 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 ]

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: TMC114

Study Arms / Comparison Groups

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

555

Completion Date

December 2008

Primary Completion Date

February 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00081588

Responsible Party

Compound Development Team Leader TMC114, Tibotec Pharmaceutical Limited

Study ID Numbers ^ICMJE

CR006724, TMC114-C215

Study Sponsor ^ICMJE

Tibotec Pharmaceuticals, Ireland

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Tibotec Pharmaceuticals Limited Clinical Trial

Tibotec Pharmaceutical Limited

Information Provided By

Tibotec Pharmaceuticals, Ireland

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP