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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
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

June 23, 2005
March 6, 2014
April 2004
August 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Rate of HIV infection at 14 weeks.
Complete list of historical versions of study NCT00115648 on ClinicalTrials.gov Archive Site
To determine overall infant survival rates at 6, 12, 18 and 24 months. [ Time Frame: 6,12,18 & 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Drug: Nevirapine
    Oral NVP daily dosage
    Other Name: Nevirapine
  • 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
  • Drug: NVP
    Oral NVP daily to age 14 weeks
    Other Name: Nevirapine
  • Drug: NVP+AZT
    Oral NVP daily plus oral AZT daly to age 14 weeks
    Other Name: Nevirapine plus zidovudine
  • Active Comparator: A
    Single dose NVP + ZDV daily for the first week.
    Interventions:
    • Drug: Nevirapine
    • Drug: AZT
    • Drug: NVP and AZT
  • Experimental: C
    Arm A plus NVP + ZDV daily to age 14 weeks.
    Interventions:
    • Drug: Nevirapine
    • Drug: AZT
    • Drug: NVP+AZT
  • Experimental: B
    Arm A plus oral NVP daily to age 14 weeks.
    Interventions:
    • Drug: Nevirapine
    • Drug: NVP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3300
October 2009
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 54 Years
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00115648
PEPI-Malawi
Yes
Michael Thigpen, Medical Officer, Centers for Disease Control and Prevention
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)
Principal Investigator: Taha E Taha, MD PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP