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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: |
NCT00074399 |
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Date of registration:
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11/12/2003 |
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Primary sponsor: |
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Public title:
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Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
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Scientific title:
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Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant |
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Date of first enrolment:
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February 2001 |
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Target sample size:
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775 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00074399 |
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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: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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Countries of recruitment
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Ethiopia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV infection, documented on two separate specimens
- Estimated gestational age at enrollment of 32 weeks or more as indicated by last
menstrual cycle and fundal height
- Permanent residency in Addis Ababa
- Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital,
Gandhi hospital, or St. Paul's Hospital)
- Hemoglobin >= 7.5 gm/dl within 4 weeks prior to study entry
- Serum glutamic pyruvic transaminase (SGPT) < 5 times upper limit of normal within 4
weeks prior to study entry
- Serum creatinine < 1.5 mg/dl within 4 weeks prior to study entry
- Consent form signed by the mother and, when possible, by the father, prior to the
onset of labor
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Nevirapine
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Drug: Nevirapine placebo
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Primary Outcome(s)
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Infant HIV infection status
[Time Frame: At Months 6 and 12]
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Secondary Outcome(s)
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Infant morbidity rate
[Time Frame: Throughout study]
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Infant mortality rate
[Time Frame: Throughout study]
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Secondary ID(s)
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5R01AI038576-05
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NIGAT Project
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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