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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00000634
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.
Patients must have the following:
* HIV infection.
* Parent or guardian must be available to give written informed consent.
Exclusion Criteria
Concurrent Medication:
Excluded:
* Zidovudine (AZT).
* Steroid dependency.
Excluded within 1 hour before and 4 hours after study drug administration:
* Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).
* Benzodiazepines.
* Alcohol-containing substances.
Concurrent Treatment:
Excluded:
* Requiring supplemental oxygen.
Patients with the following are excluded:
* Active opportunistic or serious bacterial infection.
* Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 \< 70 mm Hg.
* Pre-existing malignancies.
Prior Medication:
Excluded:
* Zidovudine (AZT) within 7 days prior to administration of study drug.
Excluded for at least 4 weeks prior to drug administration:
* Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications.
Prior Treatment:
Excluded:
* Red blood cell transfusion within 4 weeks of study entry.
Patients may not have the following:
* Opportunistic or serious bacterial infection.
Zidovudine (AZT) \> 7 days prior to administration of study drug.
Active alcohol or drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
13 Years
Study:
NCT00000634
Study Brief:
Protocol Section:
NCT00000634