Back to resultsExtended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
Malawi
Study Type
Interventional
Intervention
Nevirapine
AZT
NVP and AZT
NVP
NVP+AZT
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, MTCT, Infants, africa, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria: Had given birth within the last 24 hours 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: HIV negative 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
Sites / Locations
- College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
A
C
B
Arm Description
Single dose NVP + ZDV daily for the first week.
Arm A plus NVP + ZDV daily to age 14 weeks.
Arm A plus oral NVP daily to age 14 weeks.
Outcomes
Primary Outcome Measures
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
Secondary Outcome Measures
To determine overall infant survival rates at 6, 12, 18 and 24 months.
Full Information
NCT ID
NCT00115648
First Posted
June 23, 2005
Last Updated
March 6, 2014
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00115648
Brief Title
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Official Title
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
Detailed Description
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, MTCT, Infants, africa, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Single dose NVP + ZDV daily for the first week.
Arm Title
C
Arm Type
Experimental
Arm Description
Arm A plus NVP + ZDV daily to age 14 weeks.
Arm Title
B
Arm Type
Experimental
Arm Description
Arm A plus oral NVP daily to age 14 weeks.
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Description
Oral NVP daily dosage
Intervention Type
Drug
Intervention Name(s)
AZT
Other Intervention Name(s)
Zidovuidne (ZDV)
Intervention Description
Oral AZT daily
Intervention Type
Drug
Intervention Name(s)
NVP and AZT
Other Intervention Name(s)
Nevirapine and zidovudine
Intervention Description
Oral single dose NVP plus oral daily AZT during the first weeks
Intervention Type
Drug
Intervention Name(s)
NVP
Other Intervention Name(s)
Nevirapine
Intervention Description
Oral NVP daily to age 14 weeks
Intervention Type
Drug
Intervention Name(s)
NVP+AZT
Other Intervention Name(s)
Nevirapine plus zidovudine
Intervention Description
Oral NVP daily plus oral AZT daly to age 14 weeks
Primary Outcome Measure Information:
Title
A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
To determine overall infant survival rates at 6, 12, 18 and 24 months.
Time Frame
6,12,18 & 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had given birth within the last 24 hours
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:
HIV negative
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taha E Taha, MD PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Medicine
City
Blantyre
ZIP/Postal Code
1331
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
26525557
Citation
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.
Results Reference
derived
PubMed Identifier
26244396
Citation
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.
Results Reference
derived
PubMed Identifier
21423025
Citation
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.
Results Reference
derived
PubMed Identifier
18525035
Citation
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. Erratum In: N Engl J Med. 2018 Jun 13;:null.
Results Reference
derived
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Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
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