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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Thai Red Cross AIDS Research Centre
Sponsor:
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT02151838
First received: May 28, 2014
Last updated: October 15, 2014
Last verified: September 2010
  Purpose

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
HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Red Cross AIDS Research Centre

Resource links provided by NLM:


Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • HIV-infected pregnant women [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems


Estimated Enrollment: 250
Study Start Date: September 2008
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02151838

Contacts
Contact: Dr. Nittaya Phanuphak, MD 881 8184143 nittaya.p@trcarc.org
Contact: Somsong Teeratakulpisarn 02 2530996 tsomsong@trcarc.org

Locations
Thailand
The Thai Red Cross AIDS Research Centre Recruiting
Pathumwan,, Bangkok, Thailand, 10330
Contact: Dr.Nittaya Phanuphak, MD    881 825 3544    nittaya.p@trcarc.org   
Contact: Somsong Teeratakulpisarn    662 253 0996    tsomsong@trcarc.org   
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
  More Information

No publications provided

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT02151838     History of Changes
Other Study ID Numbers: TRCS PMTCT
Study First Received: May 28, 2014
Last Updated: October 15, 2014
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on October 23, 2014