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

Sponsor:	Tibotec Pharmaceuticals, Ireland
Information provided by:	Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:	NCT00081588

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.

Condition	Intervention	Phase
HIV Infection	Drug: TMC114	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Darunavir Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	555
Study Start Date:	November 2003
Study Completion Date:	December 2008
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: TMC114 600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081588

Sponsors and Collaborators

Tibotec Pharmaceuticals, Ireland

Investigators

Study Director:

Tibotec Pharmaceuticals Limited Clinical Trial

Tibotec Pharmaceutical Limited

More Information

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.

Responsible Party:	Tibotec Pharmaceutical Limited ( Compound Development Team Leader TMC114 )
Study ID Numbers:	CR006724, TMC114-C215
Study First Received:	April 15, 2004
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00081588 History of Changes
Health Authority:	United States: Food and Drug Administration; Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:

HIV infections
TMC114-C202
TMC114-C213
TMC114-C215
Ritonavir

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Darunavir
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009