We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00081588
Recruitment Status : Completed
First Posted : April 19, 2004
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: TMC114 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
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.
Study Start Date : November 2003
Primary Completion Date : September 2005
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081588


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

Publications:
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00081588     History of Changes
Obsolete Identifiers: NCT00980226
Other Study ID Numbers: CR006724
TMC114-C215
First Posted: April 19, 2004    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014

Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC114-C215
Ritonavir
HIV infections
TMC114-C202
TMC114-C213

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
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents