Clinical Trials

MainTitle

Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort (SEARCH004)

This study has been completed
Sponsor
Thai Red Cross AIDS Research Centre

Collaborator
Walter Reed Army Institute of Research (WRAIR)

Information provided by (Responsible Party)
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier
NCT00989144

First received: October 1, 2009
Last updated: October 28, 2009
Last Verified: October 2009
History of Changes
Purpose

Purpose

The study of early, acute HIV infection is critical to understanding subtype-specific pathophysiologic differences, since up to 50% of acute HIV infections may be incapacitating. This study will establish whether the patient population of the Thai Red Cross Anonymous Clinic is suitable for the study of early, acute infection.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

Further study details as provided by Thai Red Cross AIDS Research Centre:

Biospecimen Retention: Samples With DNA
Pools will be made by aliquoting 40ul per subject into each pool, with a maximum of 20 subjects per pool, yielding a maximum pool volume of 800 ul. Samples will be run with the Roche Amplicor ver 1.5 test in ultrasensitive mode with appropriate controls as per manufacturer's instructions. Quality assurance will be per SOP. Pools testing positive will be re-analyzed at the individual sample level. Positive samples will be confirmed by Bayer bDNA NAT. Frequency of infection will be tabulated.

Enrollment: 1000
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This study will utilize existing (collected after 1 January 2006) and prospectively collected HIV seronegative clinical specimens not used as part of any research protocol. The specimens in this study are discarded anonymous samples from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand. The specimens cannot be linked to the tested subjects. The samples will be labeled using the anonymous clinic identification number which is a 7 digit number with the first 2 digits representing the year and the following 5 digits representing the sequence of which the client sought care in that calendar year. Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

The client from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand.

Criteria

Inclusion Criteria:

  • All clients who access services included in the "Health Check Up Packages by Age
Groups" at the Thai Red Cross AIDS Research Centre.

Exclusion Criteria:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989144

Locations

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

Sponsors and Collaborators

Thai Red Cross AIDS Research Centre
Walter Reed Army Institute of Research (WRAIR)
More Information

More Information


Responsible Party: Jintanat Ananworanich, SEARCH  
ClinicalTrials.gov Identifier: NCT00989144   History of Changes  
Other Study ID Numbers: SEARCH004  
Study First Received: October 1, 2009  
Last Updated: October 28, 2009  

Keywords provided by Thai Red Cross AIDS Research Centre:

HIV seronegative
acute infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.