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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by:
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT00989144
First received: October 1, 2009
Last updated: October 28, 2009
Last verified: October 2009

October 1, 2009
October 28, 2009
January 2007
October 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00989144 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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

HIV Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
October 2008
October 2008   (final data collection date for primary outcome measure)

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:

  • None
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00989144
SEARCH004
No
Jintanat Ananworanich, SEARCH
Thai Red Cross AIDS Research Centre
Walter Reed Army Institute of Research (WRAIR)
Not Provided
Thai Red Cross AIDS Research Centre
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP