Botswana Diarrheal Diseases Study
This study has been completed.
Sponsor:
Harvard School of Public Health
Collaborator:
Botswana Ministry of Health
Information provided by (Responsible Party):
Roger Shapiro, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197652
First received: September 12, 2005
Last updated: October 6, 2011
Last verified: October 2011
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The goals of this study are to:
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 |
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HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Botswana Diarrheal Diseases Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Harvard School of Public Health:
Primary Outcome Measures:
- OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Enrollment: | 1350 |
Study Start Date: | March 2001 |
Study Completion Date: | March 2008 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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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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![](https://webarchive.library.unt.edu/web/20130309094726im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Study Population
Primary care clinic
Criteria
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.
![](https://webarchive.library.unt.edu/web/20130309094726im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197652
Locations
Botswana | |
Princess Marina Hospital | |
Gaborone, Botswana |
Sponsors and Collaborators
Harvard School of Public Health
Botswana Ministry of Health
Investigators
Principal Investigator: | Roger Shapiro, MD | Harvard School of Public Health |
![](https://webarchive.library.unt.edu/web/20130309094726im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided by Harvard School of Public Health
Additional 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: | K23 HD001330-05 |
Study First Received: | September 12, 2005 |
Last Updated: | October 6, 2011 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Harvard School of Public Health:
Prevention of Mother-Infant HIV Transmission |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Diarrhea Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on March 07, 2013