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Clinical Trials/ISRCTN71468401
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.

Registry
who.int
Start Date
April 1, 2004
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
World Health Organization (WHO) (Switzerland)

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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