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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002066
• Other study ID #: 015A
• Secondary ID: 07 32 005
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 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 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.

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.

Prior Medication:

Allowed:

• Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded.

Concurrent Medication:

Excluded within 90 days of study entry:

• Zidovudine (AZT).

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:

• Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.

• AIDS as defined by the CDC (except for those with HIV "wasting syndrome").

• Significant hepatic disease.

• Thrombocytopenia (< 75000 platelets/mm3).

Patient must voluntarily sign consent and be 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.

• Patients with HIV "wasting syndrome" are included.

Intravenous drug abuse.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection

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,