Botswana Diarrheal Diseases Study

This study has been completed.

Sponsor:

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

History of Changes

Purpose

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
HIV Infections


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Botswana Diarrheal Diseases Study

Resource links provided by NLM:

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
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.

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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