A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

Immunobiology Research Institute

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Thymopentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002050

015D

H87-75

Details and patient eligibility

About

Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to 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 Medication:

Allowed:

• Aerosolized pentamidine.

Patients must have the following:

• Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
• HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' PBMC on two separate occasions.
• Voluntarily sign consent.
• Patients with HIV "wasting syndrome" are allowed.

Prior Medication:

Allowed:

• Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• AIDS as defined by the CDC.
• Significant hepatic disease.
• Thrombocytopenia.
• Hypersensitivity to thymopentin.
• Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
• Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Patients with the following are excluded:

• AIDS as defined by the CDC.
• Significant hepatic disease.
• Thrombocytopenia.
• Hypersensitivity to thymopentin.
• Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
• Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Prior Medication:

Excluded within 30 days of study entry:

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

Intravenous drug abuse.