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

Sponsor
Thai Red Cross AIDS Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02151838
Collaborator
(none)
250
Enrollment
1
Location
154
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Thai Red Cross AIDS Research Centre
    Actual Study Start Date :
    Sep 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Jul 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 The Thai Red Cross AIDS Research Centre Pathum Wan Bangkok Thailand 10330

    Sponsors and Collaborators

    • Thai Red Cross AIDS Research Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thai Red Cross AIDS Research Centre
    ClinicalTrials.gov Identifier:
    NCT02151838
    Other Study ID Numbers:
    • TRCS PMTCT
    First Posted:
    May 30, 2014
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Thai Red Cross AIDS Research Centre
    HIV-infected pregnant women who request HAART from the TRCSPMTCT

    Study Results

    No Results Posted as of Jul 12, 2021