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

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ClinicalTrials.gov Identifier: NCT02151838
Recruitment Status : Enrolling by invitation
First Posted : May 30, 2014
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Brief 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)

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

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

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Red Cross AIDS Research Centre
Study Start Date : September 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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



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.


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
Pathum Wan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT02151838     History of Changes
Other Study ID Numbers: TRCS PMTCT
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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