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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002049
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
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.
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Interventional
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Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Thymopentin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002049
015B
H87-047
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Immunobiology Research Institute
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NIH AIDS Clinical Trials Information Service
August 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP