Botswana Diarrheal Diseases Study

This study is currently recruiting participants.

Verified by Harvard School of Public Health, February 2005

Sponsors and Collaborators:	Harvard School of Public Health Botswana Ministry of Health
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197652

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 and
link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

Condition	Intervention
HIV Infections	Drug: Nevirapine Drug: Zidovudine

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double-Blind, Placebo Control, Factorial Assignment

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197652

Contacts

Contact: Roger Shapiro, MD

617-432-1023

rshapiro@hsph.harvard.edu

Locations

Botswana
Princess Marina Hospital	Recruiting
Gaborone, Botswana
Contact: Ibou Thior, MD 723 02 632

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 indexed to this study:

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.

Study ID Numbers:	K23 HD001330-05
Study First Received:	September 12, 2005
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00197652
Health Authority:	United States: Institutional Review Board

Keywords provided by Harvard School of Public Health:

Prevention of Mother-Infant HIV Transmission

Study placed in the following topic categories:

Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009