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

Sponsor:

Collaborator:

Botswana Ministry of Health

Information provided by (Responsible Party):

Roger Shapiro, Harvard School of Public Health

Study Description

Brief Summary:

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 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
Actual Primary Completion Date :	October 2003
Actual 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

Group/Cohort
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 :

OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: 24 months ]

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

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.

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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034.

Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. Epub 2007 Jul 9.


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

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