Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346762
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2006-06-29
Brief Title:
Evaluating Host and Viral Factors Among HIV Infected Former Commercial Blood Donors in Fuyang Anhui Province China
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Host and Viral Factors in HIV-1-Infected Typical Progressors and Long-Term Survivors Among Former Blood Donors in Anhui Province China
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 the role of host and viral factors in HIV disease progression in this unique HIV infected population
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 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 screeningenrollment visit and a follow-up visit On the first day of screeningenrollment 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 screeningenrollment visit Any participant with a CD4 count less than 200 cellsmm3 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 cellsmm3 or more will be invited to enroll in Stage II
Stage II is a longitudinal prospective study and will last 195 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 screeningenrollment visit a follow-up visit 2 weeks after screeningenrollment and Months 6 12 and 18 Screeningenrollment 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
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 screeningenrollment visit and a follow-up visit On the first day of screeningenrollment 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 screeningenrollment visit Any participant with a CD4 count less than 200 cellsmm3 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 cellsmm3 or more will be invited to enroll in Stage II
Stage II is a longitudinal prospective study and will last 195 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 screeningenrollment visit a follow-up visit 2 weeks after screeningenrollment and Months 6 12 and 18 Screeningenrollment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10402 | REGISTRY | DAIDS ES | None |
| CIPRA | None | None | None |
| Project 3 | None | None | None |