Evaluating Host and Viral Factors Among HIV Infected Former Commercial Blood Donors in Fuyang, Anhui Province, China

HIV Infections Clinical Trial

Official title:

Host and Viral Factors in HIV-1-Infected Typical Progressors and Long-Term Survivors Among Former Blood Donors in Anhui Province, China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346762
• Other study ID #: CIPRA CH 003
• Secondary ID: CIPRAProject 310
• Status: Completed
• Phase: N/A
• First received: June 29, 2006
• Last updated: May 16, 2014
• Start date: September 2005
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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 the role of host and viral factors in HIV disease progression in this unique HIV infected population.

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, Anhui Province, China, unregulated commercial blood collection occurred from 1992 to 1995; during the last decade or so, some HIV infected FBDs have progressed to AIDS, while others are long-term nonprogressors, not requiring antiretroviral therapy (ART). Since the HIV infected participants in this study are predicted to have been infected by the same or related HIV strain because of their location and how they were infected, this is a unique population to study. It is hypothesized that host factors, such as host immunity and genetic background, are better predictors of disease progression than viral factors in this population. This study will enroll HIV-1 infected FBDs and age-matched HIV uninfected adults in Fuyang, Anhui Province, China.

There are two stages in this study. Stage I is a cross-sectional study and will last 3 months. Participants will be HIV-1 infected FBDs and age-matched HIV uninfected controls. There are two study visits in Stage I; there will be a 2-day screening/enrollment visit and a follow-up visit. On the first day of screening/enrollment, participants will be briefed about the study and will be asked to complete demographic and risk factor questionnaires; medical and medication history will be reviewed and a physical examination will also occur. All participants will receive HIV prevention education and risk reduction counseling; additionally, HIV uninfected participants will receive HIV pretest counseling. On the second day of screening, participants will return to the clinic for blood collection, and females will undergo a pregnancy test. All participants will return to the clinic to receive their laboratory results and post-test counseling at a follow-up visit occurring approximately 2 weeks after their screening/enrollment visit. Any participant with a CD4 count less than 200 cells/mm3 or meeting other China Comprehensive AIDS Response (CARES) treatment criteria will be referred for further evaluation and care. HIV infected FBD participants with a CD4 count of 200 cells/mm3 or more will be invited to enroll in Stage II.

Stage II is a longitudinal, prospective study and will last 19.5 months. Stage II will enroll eligible HIV infected participants from Stage I and if necessary, other eligible patients referred from China CARES. There will be at least five study visits; they will occur at a 2-day study screening/enrollment visit, a follow-up visit 2 weeks after screening/enrollment, and Months 6, 12, and 18. Screening/enrollment and follow-up visit procedures will be identical to those conducted in Stage I. Visits at Months 6, 12, and 18 will occur over 2-day periods. Medical and medication history will be reviewed and a physical examination will occur on the first day; participants will need to return to the clinic for blood collection on the second day. Participants will receive laboratory results and post-test counseling at the next scheduled study visit. Additional study visits may be required if a participant experiences any clinically significant condition during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Education
HIV prevention education and risk reduction counselig

Locations

Country	Name	City	State
China	Fuyang Prefecture Endemic Station, Anhui Province CIPRA CRS	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Comprehensive International Program of Research on AIDS

Country where clinical trial is conducted

China, 

References & Publications (2)

Wu Z, Rou K, Cui H. The HIV/AIDS epidemic in China: history, current strategies and future challenges. AIDS Educ Prev. 2004 Jun;16(3 Suppl A):7-17. Review. — View Citation

Xu JQ, Wang JJ, Han LF, Xu C, Ruan YH, Xu ZH, Chen X, Liu ZD, Wang J, Su B, Ding XP, Gao B, Gu YB, Cao XY, Xing H, Hong KX, Peng H, Zhao QB, Yuan L, Feng Y, Zhang GY, Ma LY, Wu L, Shao YM. Epidemiology, clinical and laboratory characteristics of currently — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CD4 count		At Month 3	Yes
Primary	Progression of HIV-1 disease		At Month 22	Yes

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