Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT00115050
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00115050
Study Brief:
Protocol Section:
NCT00115050