TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00115050
First received: June 20, 2005
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial.


Condition Intervention Phase
HIV Infections
Drug: TMC114
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Safety Study of TMC114 in Combination With Low Dose RTV and Other ARVs in Highly Experienced HIV-1 Infected Patients With Limited or no Treatment Options.

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • The primary objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs

Secondary Outcome Measures:
  • The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs.

Enrollment: 260
Study Start Date: June 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This is an open-label non-randomized safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial. The safety and tolerability of TMC114 in combination with low dose ritonavir (RTV) and other ARVs in highly ARV-experienced HIV-1 infected patients with limited or no treatment options will be assessed. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient. Total daily dose is 600 mg TMC114 twice daily, each intake in combination with one capsule of 100 mg Ritonavir. Since TMC114 is formulated as 300mg tablets (F014) this means 2X2 tablets per day, taken orally. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient.

  Eligibility

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

Inclusion Criteria:

  • Patient has voluntarily signed the informed consent before initiation of study procedures
  • Patient with documented HIV-1 infection
  • Patient has limited or no treatment options because of multiple treatment failures
  • Negative pregnancy test for females of childbearing potential
  • CD4 cell count < or = 100 cells/mm³
  • Viral load > or = 10,000 copies/mL.

Exclusion Criteria:

  • Primary HIV infection, patient is eligible for other Tibotec-sponsored trials
  • Prior or current participation in a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients)
  • Use of disallowed concomitant therapy
  • Use of investigational medication during the trial or within the last 90 days
  • Female patients who are pregnant or breast feeding or of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial-related activity
  • Patients with previously demonstrated clinically significant allergy or hypersensitivity to any or the excipients of the investigational medication (TMC114)
  • Patients with the laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) table (updated version from December 2004) Any grade 3 or 4 toxicity with the following exceptions: Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4
  • Patients with asymptomatic triglyceride elevations of grade 3 or 4, patients with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective or liver enzyme levels
  • Note: Patients co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Patients diagnosed with acute viral hepatitis at screening will not be allowed to enroll.
  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 ClinicalTrials.gov identifier: NCT00115050

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00115050     History of Changes
Other Study ID Numbers: CR002755
Study First Received: June 20, 2005
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV infections
Antiretroviral
TMC114
Ritonavir
Safety, TMC114-C209

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Darunavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014