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Completed

NCT Number: NCT02151838

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

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)

Completed

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Key information

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Registry information

Official study title

The Thai Red Cross AIDS Research Centre

Important dates

Study start
2008
Primary completion
2020
Study completion
2021
First posted
May 30, 2014
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.