Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Immunobiology Research Institute
Treatments:
Thymopentin
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.