Zambia Exclusive Breastfeeding Study
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ClinicalTrials.gov Identifier: NCT00310726 |
Recruitment Status
:
Completed
First Posted
: April 4, 2006
Last Update Posted
: July 27, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Other: abrupt weaning at 4 months Other: Continued exclusive breastfeeding | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1435 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission |
Study Start Date : | May 2001 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: Abrupt Weaning
Women were counseled to abruptly wean their child at 4 months of age.
|
Other: abrupt weaning at 4 months
abrupt weaning at 4 months
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Active Comparator: Exclusive breastfeeding per WHO guidelines
Women were counseled to adhere to the WHO recommendations for duration of exclusive breastfeeding.
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Other: Continued exclusive breastfeeding
Continued exclusive breastfeeding
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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 ]
- 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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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310726
Zambia | |
George and Chawama District Health Clinics | |
Lusaka, Zambia |
Principal Investigator: | Louise Kuhn, PhD | Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University | |
Principal Investigator: | Donald M Thea, MD, MSc | Department of International Health, Boston University School of Public Health |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Donald M. Thea, Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT00310726 History of Changes |
Other Study ID Numbers: |
R01HD039611 ( U.S. NIH Grant/Contract ) |
First Posted: | April 4, 2006 Key Record Dates |
Last Update Posted: | July 27, 2011 |
Last Verified: | July 2011 |
Keywords provided by Boston Medical Center:
Mother to Child Transmission of HIV Postnatal HIV transmission HIV |
Breastfeeding Perinatal HIV Transmission HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |