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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT00258557
Eligibility Criteria:
Inclusion Criteria:
* Patients with documented HIV-1 infection
* Screening plasma HIV-1 RNA \>= 5000 copies/mL
* Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines
* Patients who can comply with the protocol requirements
* General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Exclusion Criteria:
* Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection
* Life expectancy of less than 6 months
* Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity
* Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
* -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) \< 70 mL/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00258557
Study Brief:
Protocol Section:
NCT00258557