Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort (SEARCH004)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.|
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.
|Study Start Date:||January 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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.