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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00005918
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18).
* Have a viral load of at least 2,000 copies/ml within 21 days of study entry.
* Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry.
* Agree to use a barrier method of birth control (such as condoms) during the study.
* Are available for follow-up for at least 56 weeks.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Are pregnant or breast-feeding.
* Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 30 days and within 14 days of study entry.
* Have a new opportunistic (HIV-related) infection or condition requiring treatment.
* Have acute (early) HIV infection.
* Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry.
* Abuse alcohol or drugs.
* Have active hepatitis within 30 days prior to study entry.
* Have a history of peripheral neuropathy (a condition affecting the nervous system).
* Cannot take medications by mouth.
* Are allergic to certain antiviral drugs.
* Need to take certain medications that should not be taken with EFV.
* Have certain other conditions or prior treatments that might affect the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00005918
Study Brief:
Protocol Section:
NCT00005918