Botswana Diarrheal Diseases Study

N/ACompletedNCT00197652

Harvard School of Public Health (HSPH)1,350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,350

Conditions

HIV Infections

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Princess Marina Hospital

Gaborone, Botswana

Outcomes

Primary Outcomes

OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE

Time frame: 24 months

Data from ClinicalTrials.gov

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