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

HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT Clinical Trial

Official title:

The Thai Red Cross AIDS Research Centre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151838
• Other study ID #: TRCS PMTCT
• Status: Completed
• Start date: September 2008
• Est. completion date: July 2021

Study information

• Verified date: July 2021
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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