Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

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ClinicalTrials.gov Identifier: NCT00115648

Recruitment Status : Completed

First Posted : June 24, 2005

Last Update Posted : March 7, 2014

Sponsor:

Collaborators:

Centers for Disease Control and Prevention

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by:

Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Nevirapine Drug: AZT Drug: NVP and AZT Drug: NVP Drug: NVP+AZT	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	3300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Study Start Date :	April 2004
Actual Primary Completion Date :	August 2007
Actual Study Completion Date :	October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A Single dose NVP + ZDV daily for the first week.	Drug: Nevirapine Oral NVP daily dosage Drug: AZT Oral AZT daily Other Name: Zidovuidne (ZDV) Drug: NVP and AZT Oral single dose NVP plus oral daily AZT during the first weeks Other Name: Nevirapine and zidovudine
Experimental: C Arm A plus NVP + ZDV daily to age 14 weeks.	Drug: Nevirapine Oral NVP daily dosage Drug: AZT Oral AZT daily Other Name: Zidovuidne (ZDV) Drug: NVP+AZT Oral NVP daily plus oral AZT daly to age 14 weeks Other Name: Nevirapine plus zidovudine
Experimental: B Arm A plus oral NVP daily to age 14 weeks.	Drug: Nevirapine Oral NVP daily dosage Drug: NVP Oral NVP daily to age 14 weeks Other Name: Nevirapine

Outcome Measures

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. [ Time Frame: 9 months ]

Secondary Outcome Measures :

To determine overall infant survival rates at 6, 12, 18 and 24 months. [ Time Frame: 6,12,18 & 24 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 54 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT00115648

Locations


Malawi
College of Medicine
Blantyre, Malawi, 1331

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Centers for Disease Control and Prevention

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Taha E Taha, MD PhD	Johns Hopkins Bloomberg School of Public Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Michael Thigpen, Medical Officer, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00115648 History of Changes
Other Study ID Numbers:	PEPI-Malawi
First Posted:	June 24, 2005 Key Record Dates
Last Update Posted:	March 7, 2014
Last Verified:	March 2014

Keywords provided by Johns Hopkins Bloomberg School of Public Health:


HIV MTCT Infants africa 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 Zidovudine Nevirapine	Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers

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