Botswana Diarrheal Diseases Study

President and Fellows of Harvard College

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT00197652

K23HD001330-05

Details and patient eligibility

About

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.

Enrollment: 1,350 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,350 participants in 2 patient groups

Diarrheal specimens from infants born to HIV infected mothers

Description:

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

Description:

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.