Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand

NCT00713531 | Completed

• 1 other identifier: SEARCH 008/RV233
• Study Type: observational
• Target: 992
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.assess incidence of HIV-1 and volunteer retention
2. 2.describe early viral load and CD4 counts
3. 3.assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
4. 4.describe volunteer risk behavior

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (5)

• number of HIV-1 infections per 100 person-years

  5 years

• Lost to follow-up on an annual basis (10% or better)

  5 years

• Post-infection viral load and CD4 count

  5 years

• Willingness to participate in HIV vaccine and prevention trials

  5 years

• Risk behavior by questionnaire

  5 years

Secondary Outcomes (2)

• HIV-1 prevalence

  5 years

• HIV-1 genotype distribution

  5 years

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SEARCH Research Foundation: lead

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Bangkok, Bangkok, 10330, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, CD4, HIV-RNA

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nittay - Phanuphak, MD.

  The Thai Red Cross AIDS Research Centre, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jintanat Ananworanich

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 11, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

TH (1)