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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002050
• Other study ID #: 015D
• Secondary ID: H87-75
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 in patients infected with HIV who do not yet have AIDS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Thymopentin

Locations

Country	Name	City	State
United States	Immunobiology Research Institute	Annandale	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Immunobiology Research Institute

Country where clinical trial is conducted

United States,