NCT00346762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

6.9 years

First QC Date

June 29, 2006

Last Update Submit

May 16, 2014

Conditions

HIV Infections

Keywords

Former Plasma DonorsCommercial Plasma DonorsLong-Term NonprogressorsHost FactorsViral FactorsHIV

Outcome Measures

Primary Outcomes (2)

  • Change in CD4 count

    At Month 3

  • Progression of HIV-1 disease

    At Month 22

Study Arms (1)

1

HIV infected former commercial blood donors (FBDs) in Fuyang, Anhui Province

Behavioral: Education

Interventions

EducationBEHAVIORAL

HIV prevention education and risk reduction counselig

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of HIV infected and uninfected blood donors

You may qualify if:

  • 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
  • HIV uninfected
  • Willing to provide locator information
  • Willing to undergo repeat HIV testing
  • 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
  • +2 more criteria

You may not qualify if:

  • Concomitant use of ART during the study
  • Pregnancy
  • Plan to leave study area for more than 6 months during the follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuyang Prefecture Endemic Station, Anhui Province CIPRA CRS

Beijing, 100050, China

Location

Related 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. doi: 10.1521/aeap.16.3.5.7.35521.

    PMID: 15262561BACKGROUND

  • 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 alive HIV-1 infected former blood donors naive to antiretroviral therapy in Anhui Province, China. Chin Med J (Engl). 2006 Dec 5;119(23):1941-8.

    PMID: 17199937RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and urine

MeSH Terms

Conditions

HIV Infections

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Yiming Shao, MD, PhD

    National Center for AIDS/STD Control and Prevention (NCAIDS), Chinese Center for Disease Control and Prevention (China CDC)

    STUDY CHAIR

  • Jianqing Xu, MD, PhD

    National Center for AIDS/STD Control and Prevention (NCAIDS), Chinese Center for Disease Control and Prevention (China CDC)

    PRINCIPAL INVESTIGATOR

  • Hui Xing, MD, MS

    National Center for AIDS/STD Control and Prevention (NCAIDS), Chinese Center for Disease Control and Prevention (China CDC)

    PRINCIPAL INVESTIGATOR

  • Yuhua Ruan, PhD

    National Center for AIDS/STD Control and Prevention (NCAIDS), Chinese Center for Disease Control and Prevention (China CDC)

    PRINCIPAL INVESTIGATOR

  • Jianjun Wang, MPH

    Anhui Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2006

First Posted

June 30, 2006

Study Start

September 1, 2005

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

CN(1)