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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00310726 |
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Date of registration:
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03/04/2006 |
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Primary sponsor: |
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Public title:
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Zambia Exclusive Breastfeeding Study
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Scientific title:
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Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission |
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Date of first enrolment:
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May 2001 |
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Target sample size:
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1435 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00310726 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Donald M Thea, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of International Health, Boston University School of Public Health |
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Name:
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Louise Kuhn, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV-positive pregnant women identified through VCT
- After counseling about the risks and benefits of feeding alternatives report that it
is their intended decision to breastfeed
- Live within the catchment area of George or Chawama clinic
- Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a
minimum of 2 lactation counseling sessions prior to delivery)
- Do not have any significant presenting illness that requires hospitalization
- Agree to adhere to the requirements of study participation (including exclusive
breastfeeding and randomization into one of two infant feeding groups at four
months).
- Willing to inform a household member (preferably husband/father) of HIV-status.
Exclusion Criteria:
- Lives outside of catchment area;
- Have known major illnesses likely to influence pregnancy outcome including diabetes,
severe renal or heart disease, or active tuberculosis, prior to randomization;
- Does not intend to breastfeed;
- Prior enrollment in this study or concurrent enrollment in another study
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV Infection
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Intervention(s)
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Other: abrupt weaning at 4 months
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Other: Continued exclusive breastfeeding
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Primary Outcome(s)
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HIV infection detected by 4 months among children with no evidence of HIV infection at birth.
[Time Frame: 24 months of age]
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Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
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Secondary ID(s)
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R01-HD39611
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R01HD039611
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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