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

June 2, 2011 updated by: Tibotec Pharmaceuticals, Ireland

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tibotec Pharmaceuticals, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria

June 20, 2005

First Posted (Estimate)

June 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 2, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002755

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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