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

NCT ID: NCT02151838

Last Updated: 2021-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2021-07-31

Brief Summary

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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

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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

Conditions

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HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Thai Red Cross AIDS Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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TRCS PMTCT

Identifier Type: -

Identifier Source: org_study_id

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