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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002066
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1989

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002066 on ClinicalTrials.gov Archive Site
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Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

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.

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Interventional
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Masking: Double-Blind
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.

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002066
015A, 07 32 005
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Immunobiology Research Institute
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NIH AIDS Clinical Trials Information Service
November 1989

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