A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs

Launched by IMMUNOBIOLOGY RESEARCH INSTITUTE · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

Gender

ALL

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.