HIV Infections Clinical Trial
The purpose of this study is to assess populations in Thailand at high risk for HIV-1
infection for potential efficacy trials of candidate HIV vaccines to include:
1. assess incidence of HIV-1 and volunteer retention
2. describe early viral load and CD4 counts
3. assess participant willingness to participate in HIV vaccine efficacy trials and other
HIV prevention trials
4. describe volunteer risk behavior
Status | Completed |
Enrollment | 992 |
Est. completion date | June 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Man or woman aged 18-50 years - Willing to provide location or contact information and allow contact - Thai citizenship as identified by Thai National Identification card - Ability and willingness to provide consent - Availability for follow-up for the planned study duration Exclusion Criteria: - Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent - Persons who are known to be HIV-positive |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Thailand | The Thai Red Cross AIDS Research Centre | Bangkok |
Lead Sponsor | Collaborator |
---|---|
South East Asia Research Collaboration with Hawaii |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of HIV-1 infections per 100 person-years | 5 years | No | |
Primary | Lost to follow-up on an annual basis (10% or better) | 5 years | No | |
Primary | Post-infection viral load and CD4 count | 5 years | No | |
Primary | Willingness to participate in HIV vaccine and prevention trials | 5 years | No | |
Primary | Risk behavior by questionnaire | 5 years | No | |
Secondary | HIV-1 prevalence | 5 years | No | |
Secondary | HIV-1 genotype distribution | 5 years | No |
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