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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
Information provided by (Responsible Party):

Study Description
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 infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
    • comparison to rates among infants born to HIV uninfected mothers.
  2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

Condition or disease
HIV Infections

Study Design

Study Type : Observational
Actual Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Botswana Diarrheal Diseases Study
Study Start Date : March 2001
Primary Completion Date : October 2003
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

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.
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.

Outcome Measures

Primary Outcome Measures :

Eligibility Criteria

Information from the National Library of Medicine

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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
Study Population
Primary care clinic

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.
Contacts and Locations

Information from the National Library of Medicine

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

Princess Marina Hospital
Gaborone, Botswana
Sponsors and Collaborators
Harvard School of Public Health
Botswana Ministry of Health
Principal Investigator: Roger Shapiro, MD Harvard School of Public Health
More Information

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