Overview

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.