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

Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy

To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.

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

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.