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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 of patients infected with HIV who do not yet have AIDS.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunobiology Research Institute
• Treatments: Thymopentin

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' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent.

Patients with HIV "wasting syndrome" are included.

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.

• 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 (except for those with HIV "wasting syndrome").

• 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.