HIV InfectionsNCT00713531
Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand
An observational study of HIV Infections, run by SEARCH Research Foundation at 1 site in Thailand.
Trial summary
The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include: 1. assess incidence of HIV-1 and volunteer retention 2. describe early viral load and CD4 counts 3. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 992 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2008to Jun 2010
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Population in Thailand who are seeking HIV counseling and testing at TRCARC
Who may be able to join
- Man or woman aged 18-50 years
- Willing to provide location or contact information and allow contact
- Thai citizenship as identified by Thai National Identification card
- Ability and willingness to provide consent
- Availability for follow-up for the planned study duration
Who cannot join
- Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
- Persons who are known to be HIV-positive
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Bangkok, Bangkok, 10330
About this study
The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include:
- assess incidence of HIV-1 and volunteer retention
- describe early viral load and CD4 counts
- assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
- describe volunteer risk behavior
Read the detailed description
Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.
- Conditions
- HIV Infections
- Keywords
- HIV-negative, male and female clients, ages 18-50 years, seeking HIV counseling, testing at TRCARC
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
number of HIV-1 infections per 100 person-years
Measured: 5 years
Lost to follow-up on an annual basis (10% or better)
Measured: 5 years
Post-infection viral load and CD4 count
Measured: 5 years
Willingness to participate in HIV vaccine and prevention trials
Measured: 5 years
Risk behavior by questionnaire
Measured: 5 years
Secondary outcomes (2)
HIV-1 prevalence
Measured: 5 years
HIV-1 genotype distribution
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionJun 2010
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
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc.Prof.Jintanat Ananworanich, M.D., SEARCH Research Foundation
- Investigators
- Nittay - Phanuphak, MD., Principal investigator, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713531
- Sponsor's protocol ID
- SEARCH 008/RV233
- Status last verified
- May 2015
- First submitted
- 7 Jul 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand
- ClinicalTrials.gov ID
- NCT00713531
- Acronym / sponsor ID
- SEARCH 008/RV233
- Conditions
- HIV Infections
- Keywords
- HIV-negative, male and female clients, ages 18-50 years, seeking HIV counseling, testing at TRCARC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Jul 2008 (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 purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include:
- assess incidence of HIV-1 and volunteer retention
- describe early viral load and CD4 counts
- assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
- describe volunteer risk behavior
Detailed description
Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Population in Thailand who are seeking HIV counseling and testing at TRCARC
Key inclusion criteria (5 listed)
- Man or woman aged 18-50 years
- Willing to provide location or contact information and allow contact
- Thai citizenship as identified by Thai National Identification card
- Ability and willingness to provide consent
- Availability for follow-up for the planned study duration
Key exclusion criteria (2 listed)
- Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
- Persons who are known to be HIV-positive
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
number of HIV-1 infections per 100 person-years
Time frame: 5 years
Lost to follow-up on an annual basis (10% or better)
Time frame: 5 years
Post-infection viral load and CD4 count
Time frame: 5 years
Willingness to participate in HIV vaccine and prevention trials
Time frame: 5 years
Risk behavior by questionnaire
Time frame: 5 years
2 secondary outcomes
HIV-1 prevalence
Time frame: 5 years
HIV-1 genotype distribution
Time frame: 5 years
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 28 May 2015.
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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.
Nittay - Phanuphak, MD. principal investigator
The Thai Red Cross AIDS Research Centre, Bangkok, Thailand
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 SEARCH Research Foundation 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 5 inclusion and 2 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 28 May 2015. 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.
What does the primary outcome measure?
number of HIV-1 infections per 100 person-years (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 28 May 2015.