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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00000633
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication: Recommended:
* Prophylaxis with isoniazid in patients not previously treated.
Patients must have:
* HIV seropositivity by Western blot.
* Normal history and physical exam (generalized lymphadenopathy is acceptable).
* Mean CD4 cell count = or \> 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count \< 450 cells/mm3.
* Negative PPD test or normal chest x-ray with positive PPD (induration = or \> 5 mm).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Hepatitis B surface antigen positive.
* Evidence of an AIDS- or ARC-defining opportunistic infection.
* Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
* Active syphilis.
Patients with the following prior conditions are excluded:
* Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
* History of an AIDS- or ARC-defining opportunistic infection.
* History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
Prior Medication:
Excluded:
* Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
* Immunosuppressive medications within the previous 3 months.
* Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
* Vaccination against other pathogens within 4 weeks of initial screening laboratory work.
Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00000633
Study Brief:
Protocol Section:
NCT00000633