Status:
COMPLETED
Evaluating Host and Viral Factors Among HIV Infected Former Commercial Blood Donors in Fuyang, Anhui Province, China
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Comprehensive International Program of Research on AIDS
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
HIV infected former commercial blood donors (FBDs) in Fuyang, Anhui Province, China were infected with HIV from a common-source exposure to contaminated blood. The purpose of this study is to examine ...
Detailed Description
The HIV epidemic in China has reached a phase of exponential growth. Among the infected are FBDs in rural communities, who became infected through contaminated blood collection equipment. In Fuyang, A...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Stage I HIV Infected FBDs:
- Self-reported history of blood donation in 1995 or before
- HIV-1 infected
- ART naive
- Willing to provide locator information
- Willing to use acceptable forms of contraception
- Inclusion Criteria for Stage I HIV Uninfected Controls:
- HIV uninfected
- Willing to provide locator information
- Willing to undergo repeat HIV testing
- Inclusion Criteria for Stage II:
- Participant of Stage I OR enrolled directly from the ongoing China CARES program
- Self-reported history of blood donation in 1995 or before
- HIV-1 infected
- CD4 count of 200 cells/mm³ or more
- ART naive and willing to notify study staff prior to initiating any ART
- Clinical Stage I or II by the World Health Organization (WHO) Staging System
- Willing to adhere to the study follow-up schedule
- Willing to provide locator information
- Willing to use acceptable forms of contraception
- Exclusion Criteria for All Participants:
- Concomitant use of ART during the study
- Pregnancy
- Exclusion Criteria for Stage II:
- Plan to leave study area for more than 6 months during the follow-up period
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00346762
Start Date
September 1 2005
End Date
August 1 2012
Last Update
May 19 2014
Active Locations (1)
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1
Fuyang Prefecture Endemic Station, Anhui Province CIPRA CRS
Beijing, China, 100050