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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00002005
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV-1 seropositivity.
* Diagnosis of AIDS or AIDS related complex (ARC).
* Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
* The ability to sign a written informed consent form prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* A life expectancy of at least 3 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.
Concurrent Medication:
Excluded:
* Zidovudine (AZT).
* Corticosteroids.
* Nonsteroidal anti-inflammatory agents (NSAI).
* Other experimental therapy.
Patients with the following are excluded:
* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.
Prior Medication:
Excluded within 3 weeks of study entry:
* Zidovudine (AZT).
* Chemotherapy.
* Immunomodulators.
* Other experimental therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002005
Study Brief:
Protocol Section:
NCT00002005