Status:
COMPLETED
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
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
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 (A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00115050
Start Date
June 1 2005
End Date
June 1 2007
Last Update
June 10 2011
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