Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002049
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1989

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002049 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Thymopentin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002049
015B, H87-047
Not Provided
Not Provided
Immunobiology Research Institute
Not Provided
Not Provided
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