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The Thai Red Cross Society Prevention of Mother-To-Child Transmission of HIV (TRCS PMTCT) Program

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02151838
First Posted: May 30, 2014
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre
  Purpose
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)

Condition
HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Red Cross AIDS Research Centre

Resource links provided by NLM:


Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 250
Study Start Date: September 2008
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Detailed Description:
  1. To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program
  2. To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART
  3. To study adverse events in infants born to women who receive HAART during pregnancy
  4. To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission
  5. To establish the pilot model of care for HIV-infected pregnant women in middle income country
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study:

  1. HIV-infected pregnant women (as defined by the hospital)
  2. Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
  3. 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.
  4. Availability for follow-up for the planned study duration

Exclusion Criteria:

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151838


Locations
Thailand
The Thai Red Cross AIDS Research Centre
Pathumwan,, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
  More Information

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT02151838     History of Changes
Other Study ID Numbers: TRCS PMTCT
First Submitted: May 28, 2014
First Posted: May 30, 2014
Last Update Posted: January 19, 2017
Last Verified: October 2016

Keywords provided by Thai Red Cross AIDS Research Centre:
HIV-infected pregnant women who request HAART from the TRCSPMTCT