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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00002332
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS).
* CD4 count \<= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment).
* Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Known hypersensitivity to thymopentin or any component of the formulation.
* Significant chronic underlying medical illness that would impede study participation.
* Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment.
Concurrent Medication:
Excluded:
* Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine.
* HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry.
Patients with the following prior condition are excluded:
Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry.
Prior Medication:
Excluded:
* Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry.
Required:
* Current nucleoside analog antiretroviral treatment.
Required:
* Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.
Significant active alcohol or drug abuse sufficient to prevent study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002332
Study Brief:
Protocol Section:
NCT00002332