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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00002351
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV positivity.
* No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina.
* Body surface area at least 1.0 sqm.
* Consent of parent or guardian.
Prior Medication:
Allowed:
* Aerosolized pentamidine.
* Topical antifungals.
* TMP / SMX.
* AZT.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Significant hepatic disease including HBsAg or hepatitis C positivity.
* Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder.
* Significant cardiac disease including dysrhythmia or cardiomyopathy.
* Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results.
* Has a social situation that may interfere with study participation.
Concurrent Medication:
Excluded:
* Oral contraceptives.
Patients with the following prior conditions are excluded:
* History of serious allergic drug reactions.
* History of significant cardiac disease.
* Participation on another clinical trial within the past 4 weeks.
* Donated blood within the past 4 weeks.
Prior Medication:
Excluded within the past 4 weeks:
* Hematopoietic growth factors.
Excluded within the past 2 weeks:
* Antiretroviral agent other than zidovudine.
* Oral contraceptives.
* Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX.
* Any other medication unless approved by Merck clinical monitor. Current illicit drug use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT00002351
Study Brief:
Protocol Section:
NCT00002351