Cohort Study of HIV-1 Incidence Among Clients of the Thai REd Cross AIDS Reserch Centre, Bangkok, Thailand

This study is not yet open for participant recruitment.

Verified by South East Asia Research Collaboration with Hawaii, July 2008

First Received: July 7, 2008 No Changes Posted

Sponsor:	South East Asia Research Collaboration with Hawaii
Information provided by:	South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:	NCT00713531

Purpose

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 participante in HIV vaccine efficacy trials and other HIV prevention trials; (4) describe volunteer risk behavior

Condition
HIV Infections

Study Type:	Observational
Study Design:	Cohort, Prospective

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:

number of HIV-1 infections per 100 person-years lost to follow-up on an annual basis (10% or better) Post-infection viral load and CD4 count Willingness to participate in HIV vaccine and prevention trials and risk behavior by questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HIV-1 prevalence HIV-1 genotype distribution [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	July 2008

Detailed Description:

Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Population in Thailand who are seeking HIV counseling and testing at TRCARC

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713531

Contacts

Contact: Nittaya - Phanuphak, MD.	6622530996 ext -	nittaya.p@chula.ac.th
Contact: Duanghathai - Suttichom, BNS	662542566 ext 109	duanghathai.s@searchthailand.org

Locations

Thailand, -
The Thai Red Cross AIDS Research Centre
Bangkok, -, Thailand, 10330

Sponsors and Collaborators

South East Asia Research Collaboration with Hawaii

Investigators

Principal Investigator:

Nittay - Phanuphak, MD.

The Thai Red Cross AIDS Research Centre, Bangkok, Thailand

More Information

No publications provided

Responsible Party:	AFRIMS USA ( The Red Cross AIDS Research Centre, Bangkok, Thailand )
Study ID Numbers:	SEARCH 008/RV233
Study First Received:	July 7, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00713531 History of Changes
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by South East Asia Research Collaboration with Hawaii:

HIV-negative
male and female clients
ages 18-50 years
seeking HIV counseling
testing at TRCARC

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010