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

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)

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • The Thai Red Cross AIDS Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2008
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (ESTIMATE): May 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: HIV-infected pregnant women who request HAART from the TRCSPMTCT
• Other Study ID Numbers: TRCS PMTCT