Status:
COMPLETED
Botswana Diarrheal Diseases Study
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Botswana Ministry of Health
Conditions:
HIV Infections
Eligibility:
FEMALE
18-55 years
Brief Summary
The goals of this study are to: 1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers. * analysis by HIV status of in...
Eligibility Criteria
Inclusion
- Subject is able to provide independent informed consent.
- Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
- Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.
- For HIV-infected subjects:
- Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.
Exclusion
- Subject cannot provide legal independent informed consent.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT00197652
Start Date
March 1 2001
End Date
March 1 2008
Last Update
October 7 2011
Active Locations (1)
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1
Princess Marina Hospital
Gaborone, Botswana