skip to content

Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Johns Hopkins Bloomberg School of Public Health

Collaborator
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier
NCT00115648

First received: June 23, 2005
Last updated: March 6, 2014
Last Verified: March 2014
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : Nevirapine
Drug : AZT
Drug : NVP and AZT
Drug : NVP
Drug : NVP+AZT
Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

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 ]

Enrollment: 3300
Study Start Date: April 2004
Study Completion Date: October 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 54 Years  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


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  
Study First Received: June 23, 2005  
Last Updated: March 6, 2014  

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

HIV
MTCT
Infants
africa
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Zidovudine
Nevirapine

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.