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

NCT00115648 | Completed Phase 3 DMC

• 1 other identifier: PEPI-Malawi
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; MTCT; Infants; africa; HIV Seronegativity

Outcome Measures

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.

  9 months

Secondary Outcomes (1)

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

  6,12,18 & 24 months

Study Arms (3)

A

ACTIVE COMPARATOR

Single dose NVP + ZDV daily for the first week.

Drug: Nevirapine; Drug: AZT; Drug: NVP and AZT

C

EXPERIMENTAL

Arm A plus NVP + ZDV daily to age 14 weeks.

Drug: Nevirapine; Drug: AZT; Drug: NVP+AZT

B

EXPERIMENTAL

Arm A plus oral NVP daily to age 14 weeks.

Drug: Nevirapine; Drug: NVP

Interventions

Nevirapine DRUG

Oral NVP daily dosage

A; B; C

AZT DRUG

Oral AZT daily

Also known as: Zidovuidne (ZDV)

A; C

NVP and AZT DRUG

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

Also known as: Nevirapine and zidovudine

A

NVP DRUG

Oral NVP daily to age 14 weeks

Also known as: Nevirapine

B

NVP+AZT DRUG

Oral NVP daily plus oral AZT daly to age 14 weeks

Also known as: Nevirapine plus zidovudine

C

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• HIV negative
• Women with discordant HIV results
• Women who indicate that they will not breastfeed at time of delivery
• Newborn with life-threatening condition
• Women who previously enrolled in this study and have a second pregnancy cannot reenroll

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Centers for Disease Control and Prevention: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

College of Medicine

Blantyre, 1331, Malawi

Location

Related Publications (4)

• 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.

  PMID: 26525557 DERIVED

• 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.

  PMID: 26244396 DERIVED

• 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.

  PMID: 21423025 DERIVED

• 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.

  PMID: 18525035 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine; Zidovudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Taha E Taha, MD PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2005
• First Posted: June 24, 2005
• Study Start: April 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2009
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

MA (1)