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

This study has been completed.
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland Identifier:
First received: April 15, 2004
Last updated: June 19, 2014
Last verified: June 2014
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

Resource links provided by NLM:

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 ]

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 ]

Enrollment: 555
Study Start Date: November 2003
Study Completion Date: December 2008
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00081588

  Show 68 Study Locations
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT00081588     History of Changes
Obsolete Identifiers: NCT00980226
Other Study ID Numbers: CR006724
Study First Received: April 15, 2004
Last Updated: June 19, 2014

Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV infections

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 21, 2017