- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005309
Prospective Study of HIV Infection in Hemophiliacs
Study Overview
Status
Detailed Description
BACKGROUND:
In the late 1980s, hemophiliacs were transfused with a variety of blood products, including large amounts of cryoprecipitate. In comparison to other cohorts, hemophiliacs are CMV(-), resulting in a comparison group for the study of this virus as a potential cofactor. In contrast, non A, non-B hepatitis is common in comparison to other cohorts, and preliminary data prior to 1990 suggested that this chronic disease predisposes to more rapid progression of HIV infection.
DESIGN NARRATIVE:
Disease-free survival rates were determined in HIV-infected hemophiliacs. The effects of co-factors such as intensive transfusion, concomitant cytomegalovirus or chronic NANB hepatitis infection were ascertained. Host-virus interaction was assessed through the use of plasma cultures, specific antibody titers, and markers of immune changes detected by flow cytometry and immune function assays. The immunology of asymptomatic stable infection was investigated. The safety of volunteer donor blood products was determined in seronegative patients exposed to over 50,000 donors yearly and the risk of sexual transmission of HIV to spouses of seropositive patients was monitored.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- George Gjerset, Bloodworks
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Liver Diseases
- Blood Coagulation Disorders, Inherited
- Coagulation Protein Disorders
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- DNA Virus Infections
- Blood Coagulation Disorders
- Herpesviridae Infections
- Slow Virus Diseases
- Hepatitis
- HIV Infections
- Hemophilia A
- Infections
- Communicable Diseases
- Hematologic Diseases
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Hepatitis, Viral, Human
- Cytomegalovirus Infections
Other Study ID Numbers
- 3012
- R01HL043512 (U.S. NIH Grant/Contract)
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