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

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ClinicalTrials.gov Identifier: NCT00989144
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : October 29, 2009
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by:
Thai Red Cross AIDS Research Centre

Tracking Information
First Submitted Date October 1, 2009
First Posted Date October 2, 2009
Last Update Posted Date October 29, 2009
Study Start Date January 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00989144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort
Official Title Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
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.
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October¬†1,¬†2009)
1000
Original Actual Enrollment Same as current
Actual Study Completion Date October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility 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:

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT00989144
Other Study ID Numbers SEARCH004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jintanat Ananworanich, SEARCH
Study Sponsor Thai Red Cross AIDS Research Centre
Collaborators Walter Reed Army Institute of Research (WRAIR)
Investigators Not Provided
PRS Account Thai Red Cross AIDS Research Centre
Verification Date October 2009