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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
  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 of patients infected with HIV who do not yet have AIDS.

Condition Intervention
HIV Infections Drug: Thymopentin

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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' 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002049


Locations
United States, New Jersey
Immunobiology Research Institute
Annandale, New Jersey, United States, 088010999
Sponsors and Collaborators
Immunobiology Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00002049     History of Changes
Other Study ID Numbers: 015B
H87-047
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: August 1989

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Thymopentin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs