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:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT00002392
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Documented HIV infection.
* CD4+ cell count between 300 and 500 cells/mm3.
* HIV-1 RNA \< 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry \[AS PER AMENDMENT 11/25/98:
* Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test\].
* Established B cell lines \[deleted AS PER AMENDMENT 11/25/98\].
* Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses.
* Life expectancy \> 6 months \[deleted AS PER AMENDMENT 11/25/98\].
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Active opportunistic infection or HIV-related malignancy \[HIV-related malignancy deleted AS PER AMENDMENT 11/25/98\].
* Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.
Concurrent Medication:
Excluded:
* Other investigational HIV-drugs.
* Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.
Patients with the following prior conditions are excluded:
History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.
Prior Medication:
Excluded:
* Previous immunization with pneumococcal polysaccharide vaccine \[or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine\].
* Tetanus toxoid booster within 5 years \[deleted AS PER AMENDMENT 11/25/98\].
* Other investigational HIV-drugs within 6 weeks of enrollment.
* Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment.
Risk Behavior:
Excluded:
Active drug or alcohol abuse.
Required:
Effective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. \[AS PER AMENDMENT 11/25/98:
* On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002392
Study Brief:
Protocol Section:
NCT00002392