Botswana Diarrheal Diseases Study
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ClinicalTrials.gov Identifier: NCT00197652 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: October 7, 2011
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The goals of this study are to:
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determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.
- analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
- comparison to rates among infants born to HIV uninfected mothers.
- link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.
Condition or disease |
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HIV Infections |
Study Type : | Observational |
Actual Enrollment : | 1350 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Botswana Diarrheal Diseases Study |
Study Start Date : | March 2001 |
Actual Primary Completion Date : | October 2003 |
Actual Study Completion Date : | March 2008 |

Group/Cohort |
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Diarrheal specimens from infants born to HIV infected mothers
400 diarrheal specimens will suffice to determine the prevalence of specific pathogens in the region. Of these, 300 specimens will be collected from infants born to HIV infected mothers, and 100 specimens will be collected from infants born to HIV uninfected mothers.
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Breast milk from HIV infected and HIV uninfected women
Breast milk from HIV infected and HIV uninfected women who are breastfeeding is collected at 2 days, 2 weeks, 2 months, and 5 months post-partum. This breast milk will be compared for in vitro functional quality of immunoglobulins to selected diarrheal and respiratory pathogens.
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- OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- Subject cannot provide legal independent informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197652
Botswana | |
Princess Marina Hospital | |
Gaborone, Botswana |
Principal Investigator: | Roger Shapiro, MD | Harvard School of Public Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Roger Shapiro, Principal Investigator, Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT00197652 History of Changes |
Other Study ID Numbers: |
K23HD001330-05 ( U.S. NIH Grant/Contract ) |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | October 7, 2011 |
Last Verified: | October 2011 |
Keywords provided by Roger Shapiro, Harvard School of Public Health:
Prevention of Mother-Infant HIV Transmission |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |