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:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT00028067
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.
* Are at least 16 years old (or the minimum age by local requirements).
* Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).
* Use effective barrier method of contraception.
* Give written informed consent.
* Are available for follow-up for at least 52 weeks.
Exclusion Criteria
Patients may not be eligible for this study if they:
* Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.
* Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.
* Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.
* Are unable to demonstrate responsiveness to a provided NRTI.
* Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.
* Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.
* Have severe diarrhea within 30 days prior to study entry.
* Are pregnant or breast-feeding.
* Have a history of hemophilia.
* Have history or signs of bilateral peripheral neuropathy.
* Have cardiomyopathy.
* Have certain heart problems.
* Cannot tolerate oral medication.
* Have any other problems that would interfere with the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00028067
Study Brief:
Protocol Section:
NCT00028067