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

This study is currently recruiting participants.

Verified by Johns Hopkins Bloomberg School of Public Health, May 2008

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

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 ] [ 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
Estimated Study Completion Date:	September 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Single dose NVP + ZDV daily for the first week.	Drug: Nevirapine Oral NVP daily dosage Drug: AZT Oral AZT daily Drug: NVP and AZT Oral single dose NVP plus oral daily AZT during the first weeks
C: Experimental Arm A plus NVP + ZDV daily to age 14 weeks.	Drug: Nevirapine Oral NVP daily dosage Drug: AZT Oral AZT daily Drug: NVP+AZT Oral NVP daily plus oral AZT daly to age 14 weeks
B: Experimental 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115648

Locations

Malawi
College of Medicine	Recruiting
Blantyre, Malawi, 1331
Contact: Newton I Kumwenda, PhD 265 8 830 372 nkumwenda@jhu.medcol.mw
Principal Investigator: Newton I Kumwenda, PhD

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

Publications indexed to this study:

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. Epub 2008 Jun 4.

Responsible Party:	Centers for Disease Control and Prevention ( Michael Thigpen, Medical Officer )
Study ID Numbers:	PEPI-Malawi
Study First Received:	June 23, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00115648
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

Study placed in the following topic categories:

Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009