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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT00002166
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Patients \> 18 months of age with history of positive serology for HIV-1 infection or patients \<= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture.
* Patients \>= 13 years of age with a CD4+ cell count \<= 200 cells/mm3. Patients \< 13 years of age with a CD4% \<= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was \>=20%.
* Patient has failed or is intolerant to currently approved treatments for HIV-1 infection and is unable to participate in a controlled viramune clinical trial.
* Written and informed consent from a parent or guardian for patients \< 18 years of age.
* Patient or guardian is willing and able to follow protocol requirements. (PER AMENDMENT 1/29/97:
* Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled.)
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Patient qualifies for participation in an actively accruing Viramune controlled clinical trial.
Concurrent Medication:
Excluded:
* Dicumarol, Warfarin, and other anticoagulant medications.
* Tolbutamide.
* Investigational drugs, all protease inhibitors, and all other non-nucleoside transcriptase inhibitors.
* Neurotoxic drugs.
* Cimetidine.
* Erythromycin.
Required:
Patient has failed or is intolerant to currently approved treatments for HIV-1 infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Study:
NCT00002166
Study Brief:
Protocol Section:
NCT00002166