Botswana Pediatric Respiratory Disease and Bloodstream Infection Study

This study is currently recruiting participants.

Verified by Harvard School of Public Health, September 2005

First Received: September 13, 2005 Last Updated: March 20, 2006 History of Changes

Sponsored by:	Harvard School of Public Health
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197691

Purpose

The purpose of this study is to learn about lower respiratory tract and bloodstream diseases among infants born to HIV positive mothers in Botswana.

Study factors include how commonly infants get these diseases, the causes, and outcomes. The study will also try to measure the protective effect, if any, of breast feeding on respiratory disease illness and deaths.

Condition	Intervention
HIV Infections Respiratory Tract Diseases Sepsis	Procedure: blood draws, etc.

MedlinePlus related topics: AIDS Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participation in parent study, "Mashi" HIV vertical transmission prevention study for pregnant Botswana women and their infants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197691

Contacts

Contact: Shahin Lockman, MD

617 556-1001

slockman@hsph.harvard.edu

Locations

Botswana
Princess Marina Hospital	Recruiting
Gaborone, Botswana
Contact: Ibou Thior, MD ithior@bhp.org.bw

Sponsors and Collaborators

Harvard School of Public Health

Investigators

Principal Investigator:

Shahin Lockman, MD

Harvard School of Public Health

More Information

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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:	HSC 10027/000BOTS
Study First Received:	September 13, 2005
Last Updated:	March 20, 2006
ClinicalTrials.gov Identifier:	NCT00197691 History of Changes
Health Authority:	Botswana: Ministry of Health

Keywords provided by Harvard School of Public Health:

HIV infected mothers
Infants at risk of HIV-infection
Infant lower respiratory tract disease
Infant bloodstream infection

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Sepsis
Respiratory Tract Diseases
HIV Infections

Sexually Transmitted Diseases
Respiration Disorders
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
Respiratory Tract Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009