HIV InfectionsSEARCH004NCT00989144
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 1,000 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The client from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand.
Who may be able to join
- All clients who access services included in the "Health Check Up Packages by Age Groups" at the Thai Red Cross AIDS Research Centre.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV seronegative, acute infection
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989144
- Sponsor's protocol ID
- SEARCH004
- Acronym
- SEARCH004
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.
- ClinicalTrials.gov ID
- NCT00989144
- Acronym / sponsor ID
- SEARCH004 / SEARCH004
- Conditions
- HIV Infections
- Keywords
- HIV seronegative, acute infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- Jan 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The client from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand.
Key inclusion criteria (1 listed)
- All clients who access services included in the "Health Check Up Packages by Age Groups" at the Thai Red Cross AIDS Research Centre.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2009.