Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
NCT ID: NCT00115648
Last Updated: 2014-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3300 participants
INTERVENTIONAL
2004-04-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A
Single dose NVP + ZDV daily for the first week.
Nevirapine
Oral NVP daily dosage
AZT
Oral AZT daily
NVP and AZT
Oral single dose NVP plus oral daily AZT during the first weeks
C
Arm A plus NVP + ZDV daily to age 14 weeks.
Nevirapine
Oral NVP daily dosage
AZT
Oral AZT daily
NVP+AZT
Oral NVP daily plus oral AZT daly to age 14 weeks
B
Arm A plus oral NVP daily to age 14 weeks.
Nevirapine
Oral NVP daily dosage
NVP
Oral NVP daily to age 14 weeks
Interventions
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Nevirapine
Oral NVP daily dosage
AZT
Oral AZT daily
NVP and AZT
Oral single dose NVP plus oral daily AZT during the first weeks
NVP
Oral NVP daily to age 14 weeks
NVP+AZT
Oral NVP daily plus oral AZT daly to age 14 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to give informed consent for HIV testing and enrollment into the study
* Willing to receive HIV results
* HIV infected
* Planning to deliver or had given birth at the study clinics
* Willing to come back for follow-up visits for 2 years postnatally
* Resident of Blantyre city or its suburbs
Exclusion Criteria
* Women with discordant HIV results
* Women who indicate that they will not breastfeed at time of delivery
* Inability or unwillingness to follow any of the inclusion requirements
* Newborn with life-threatening condition
* Women who previously enrolled in this study and have a second pregnancy cannot reenroll
18 Years
54 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Centers for Disease Control and Prevention
Principal Investigators
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Taha E Taha, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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College of Medicine
Blantyre, , Malawi
Countries
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References
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Schwartz SR, Kumwenda N, Kumwenda J, Chen S, Mofenson LM, Taylor AW, Fowler MG, Taha TE. Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009. Matern Child Health J. 2016 Mar;20(3):542-9. doi: 10.1007/s10995-015-1852-5.
Redd AD, Wendel SK, Longosz AF, Fogel JM, Dadabhai S, Kumwenda N, Sun J, Walker MP, Bruno D, Martens C, Eshleman SH, Porcella SF, Quinn TC, Taha TE. Evaluation of postpartum HIV superinfection and mother-to-child transmission. AIDS. 2015 Jul 31;29(12):1567-73. doi: 10.1097/QAD.0000000000000740.
Taha TE, Li Q, Hoover DR, Mipando L, Nkanaunena K, Thigpen MC, Taylor A, Kumwenda J, Fowler MG, Mofenson LM, Kumwenda NI. Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. J Acquir Immune Defic Syndr. 2011 Aug 1;57(4):319-25. doi: 10.1097/QAI.0b013e318217877a.
Kumwenda NI, Hoover DR, Mofenson LM, Thigpen MC, Kafulafula G, Li Q, Mipando L, Nkanaunena K, Mebrahtu T, Bulterys M, Fowler MG, Taha TE. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med. 2008 Jul 10;359(2):119-29. doi: 10.1056/NEJMoa0801941. Epub 2008 Jun 4.
Other Identifiers
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PEPI-Malawi
Identifier Type: -
Identifier Source: org_study_id
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