ISRCTN71468401
Completed
Not Applicable
Impact of highly active anti-retroviral therapy (HAART) during pregnancy and breastfeeding on mother-to-child transmission (MTCT) and mother's health
World Health Organization (WHO) (Switzerland)0 sites2,400 target enrollmentApril 1, 2004
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
- Sponsor
- World Health Organization (WHO) (Switzerland)
- Enrollment
- 2400
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pregnant, with a gestational age of 28 \- 34 weeks (or between 16 and 32 weeks gestation if the woman is referred with medically\-documented HIV stage four \[clinical AIDS] or CD4\+ cell count below 200 cells/mm^3 diagnosed before study screening)
- •2\. No evidence of clinically\-significant conditions likely to require specific care arrangements and which may interfere with study interventions (obstetric, cardiac, respiratory \[including active tuberculosis], hepatic, gastrointestinal, endocrine, renal, haematologic, psychiatric, neurologic, or allergic) as assessed by the study site Principal Investigator
- •3\. Confirmation of HIV infection at the study site
- •4\. Not having received an HIV vaccine (never enrolled in an HIV\-vaccine trial)
- •5\. Willingness to receive, and no contraindication to receive, the short MTCT\-prophylaxis regimen as a minimum
- •6\. No previous enrolment in the Kesho Bora study
- •7\. Capacity and willingness to participate in all follow\-up visits, including participating in all clinical examinations, having blood drawn, as well as willingness for their infant to be clinically and physically examined and have blood drawn
- •8\. Residing, and planning to continue to reside, within a predefined, site\-specific catchment area until two years after delivery
- •9\. Ability and willingness to give informed consent for enrolment in the study
- •10\. Not currently taking Anti\-RetroViral drugs (ARV) drugs
Exclusion Criteria
- •Does not comply with the inclusion criteria above.
Outcomes
Primary Outcomes
Not specified
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