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

Completed

• Conditions: HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT

• Registration Number: NCT02151838
• Lead Sponsor: 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)

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-30
• Primary Completion: 2020-12
• Status Verified: 2021-07
• Study Completion: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV-infected pregnant women	18 months	Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems

Trial Locations

Locations (1)

The Thai Red Cross AIDS Research Centre; 🇹🇭 Pathum Wan, Bangkok, Thailand