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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00000958
Eligibility Criteria:
Inclusion Criteria
Patients must be:
* Healthy HIV-seropositive adults (generalized lymphadenopathy, seborrheic dermatitis acceptable).
* Negative for HIV plasma culture.
* Available for 6 months follow-up (patients in Pilot study) or 10 months follow-up (patients in Parts A and B).
Prior Medication: Required:
* Part B: Zidovudine (AZT), tolerating a dose of 500 - 600 mg/day for at least 4 months prior to entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Evidence of psychological disorder during the past year that would impair adherence to the protocol.
* Evidence of an AIDS defining opportunistic infection.
Prior Medication:
Excluded:
* Any potential immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
* Immunosuppressive medications during the past 3 months.
* Part A: Use of zidovudine (AZT) for more than 30 days in the preceding 6 months, or any AZT within the last 30 days.
* Parts A and B: Any non-AZT antiretroviral drug.
* Any other investigational agent within the past 30 days.
* Immunoglobulins within the past 60 days.
Patients may not have the following prior conditions:
* Evidence of psychological disorder during the past year that would impair adherence to the protocol.
* History of an AIDS-defining opportunistic infection.
Use of illicit drugs or significant amounts of alcohol that, in the opinion of the principal investigator, would interfere with compliance with the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00000958
Study Brief:
Protocol Section:
NCT00000958