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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated 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
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
Experimental: C
Arm A plus NVP + ZDV daily to age 14 weeks.
Drug: Nevirapine
Oral NVP daily dosage
Other Name: Nevirapine
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
Other Name: Nevirapine
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

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
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
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
Investigators
Principal Investigator: Taha E Taha, MD PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV
MTCT
Infants
africa
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014