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

This study has been completed.

Sponsored by: Immunobiology Research Institute
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002050
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Thymopentin

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Thymopentin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
Official Title:   A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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' 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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002050

Locations
United States, New Jersey
Immunobiology Research Institute    
      Annandale, New Jersey, United States, 088010999

Sponsors and Collaborators
Immunobiology Research Institute
  More Information


Study ID Numbers:   015D, H87-75
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002050
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Semen  
Thymopentin  
Leukocytes, Mononuclear  
AIDS-Related Complex  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Thymopentin
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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