HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCTNCT02151838
The Thai Red Cross Society Prevention of Mother-To-Child Transmission of HIV (TRCS PMTCT) Program
An observational study of HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT) Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT
- How many people
- 250 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2008to Jul 2021
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will be HIV-infected pregnant women who request HAART from the TRCS PMTCT program. These pregnant women will be under the care of the health care teams in 30 hospitals throughout Thailand which have registered with the TRCS PMTCT program since April 2004
Who may be able to join
- Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study:
- HIV-infected pregnant women (as defined by the hospital)
- Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
- Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
- Availability for follow-up for the planned study duration
Who cannot join
- Volunteers meeting any of the following criteria will be excluded from the study:
- 1.Persons who have a history of a medical or psychiatric disorder by interview and physical examination according to standard practices, that in the judgment of the treating physician, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
About this study
Official title: The Thai Red Cross AIDS Research Centre
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)
Read the detailed description
- To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program
- To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART
- To study adverse events in infants born to women who receive HAART during pregnancy
- To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission
- To establish the pilot model of care for HIV-infected pregnant women in middle income country
- Keywords
- HIV-infected pregnant women who request HAART from the TRCSPMTCT
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-infected pregnant women
Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startSep 2008
- Primary completionDec 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCTStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151838
- Sponsor's protocol ID
- TRCS PMTCT
- Status last verified
- Jul 2021
- First submitted
- 28 May 2014
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thai Red Cross AIDS Research Centre
- ClinicalTrials.gov ID
- NCT02151838
- Acronym / sponsor ID
- TRCS PMTCT
- Keywords
- HIV-infected pregnant women who request HAART from the TRCSPMTCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 30 May 2014 (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.
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)
Detailed description
- To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program
- To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART
- To study adverse events in infants born to women who receive HAART during pregnancy
- To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission
- To establish the pilot model of care for HIV-infected pregnant women in middle income country
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will be HIV-infected pregnant women who request HAART from the TRCS PMTCT program. These pregnant women will be under the care of the health care teams in 30 hospitals throughout Thailand which have registered with the TRCS PMTCT program since April 2004
Key inclusion criteria (5 listed)
- Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study:
- HIV-infected pregnant women (as defined by the hospital)
- Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
- Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
- Availability for follow-up for the planned study duration
Key exclusion criteria (2 listed)
- 1.Persons who have a history of a medical or psychiatric disorder by interview and physical examination according to standard practices, that in the judgment of the treating physician, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
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
HIV-infected pregnant women
Time frame: 18 months
Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
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 12 Jul 2021.
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-infected Pregnant Women Who Request HAART From the TRCSPMTCT, 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 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 12 Jul 2021. 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?
HIV-infected pregnant women (time frame: 18 months). 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 12 Jul 2021.