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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00000967
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Recommended:
* Prophylaxis for Pneumocystis carinii pneumonia.
Allowed:
* Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).
* Immunization according to the current recommendations of the Advisory Committee for Immunization Practice.
* IVIG. Systemic ketoconazole, acyclovir, or oral nystatin for acute therapy.
Patients must have the following:
* HIV infection. Patients with proven resistance to AZT are also eligible.
Prior Medication:
Allowed:
* Aerosol ribavirin.
Required:
Cohort C treatment:
* Stable prescribed dose of zidovudine (AZT) \>= 90 mg/m2 for at least 6 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded: AIDS or class P-2B, D, or E symptomatic infection.
Concurrent Medication:
Excluded:
* Hepatotoxic or neurotoxic drugs, immunosuppressants, or antiseizure medication. Ketoconazole, fluconazole, and acyclovir for prophylaxis. Immunomodulators (other than IVIG). Experimental drugs.
Cohort A patients:
* AZT for clinical indications.
Prior Medication:
Excluded:
* Other antiretroviral agents (including didanosine (ddI), dideoxycytidine (ddC), or soluble CD4) within 1 month of study entry. Systemic ribavirin administered for retroviral therapy within 2 months of study entry.
* Immunomodulating agents including interferon, isoprinosine, interleukin-2, or lymphocyte transfusions within 4 weeks of study entry.
* RBC transfusion within 4 weeks prior to study entry.
Alcohol or drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
17 Years
Study:
NCT00000967
Study Brief:
Protocol Section:
NCT00000967