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Completed

NCT Number: NCT00115648

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

College of Medicine

Blantyre, 1331, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nevirapine

Drug

Oral NVP daily dosage

AZT

Drug

Oral AZT daily

Other names: Zidovuidne (ZDV)

NVP and AZT

Drug

Oral single dose NVP plus oral daily AZT during the first weeks

Other names: Nevirapine and zidovudine

NVP

Drug

Oral NVP daily to age 14 weeks

Other names: Nevirapine

NVP+AZT

Drug

Oral NVP daily plus oral AZT daly to age 14 weeks

Other names: Nevirapine plus zidovudine

Primary outcomes

  1. 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 outcomes

  1. To determine overall infant survival rates at 6, 12, 18 and 24 months.

    Time frame: 6,12,18 & 24 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Jun 24, 2005
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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