NCT00989144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

October 1, 2009

Last Update Submit

October 28, 2009

Conditions

Keywords

HIV seronegativeacute infection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

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.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

January 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations