Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Immunobiology Research Institute

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Thymopentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002051

015E

H87-101

Details and patient eligibility

About

Examine the ability of thymopentin (Timunox) to:

Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Treatment:

Allowed:

• Aerosolized pentamidine.

Prior Medication:

Allowed:

• Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
• Significant hepatic disease.
• Thrombocytopenia (< 75000 platelets/mm3).
• Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to entry.
• Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
• Known hypersensitivity to thymopentin.

Prior Medication:

Excluded within 30 days of study entry:

• Immunomodulatory or experimental therapy.
• Excluded within 90 days of study entry:
• Zidovudine (AZT).

Patients must not have:

• AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
• Significant hepatic disease.
• Thrombocytopenia (< 75000 platelets/mm3).

Patients with the following conditions are included:

• Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
• HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.
• HIV "wasting syndrome".
• Must voluntarily sign consent.

History of intravenous drug abuse.