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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Official Title ^ICMJE	A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Thymopentin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002050
Responsible Party
Study ID Numbers ^ICMJE	015D, H87-75
Study Sponsor ^ICMJE	Immunobiology Research Institute
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 1989
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP