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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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 who are ineligible for participation in any other Tibotec-sponsored trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Darunavir; Ritonavir

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.