NCT00074399

Brief Summary

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission. Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
775

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

6.2 years

First QC Date

December 11, 2003

Last Update Submit

August 6, 2009

Conditions

HIV Infections

Keywords

Maternal/Infant TransmissonVertical TransmissionPregnancyHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Infant HIV infection status

    At Months 6 and 12

Secondary Outcomes (2)

  • Infant mortality rate

    Throughout study

  • Infant morbidity rate

    Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive nevirapine for 6 weeks

Drug: Nevirapine

2

PLACEBO COMPARATOR

Participants will receive nevirapine placebo for 6 weeks

Drug: Nevirapine placebo

Interventions

NevirapineDRUG

Tablet taken orally daily. Dosage depends on age and body surface area

1
Nevirapine placeboDRUG

Placebo tablet taken orally daily

2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infection, documented on two separate specimens
  • Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height
  • Permanent residency in Addis Ababa
  • Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)
  • Hemoglobin \>= 7.5 gm/dl within 4 weeks prior to study entry
  • Serum glutamic pyruvic transaminase (SGPT) \< 5 times upper limit of normal within 4 weeks prior to study entry
  • Serum creatinine \< 1.5 mg/dl within 4 weeks prior to study entry
  • Consent form signed by the mother and, when possible, by the father, prior to the onset of labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tikur Anbessa Hospital

Addis Ababa, Ethiopia

Location

Related Publications (1)

  • Six Week Extended-Dose Nevirapine (SWEN) Study Team; Bedri A, Gudetta B, Isehak A, Kumbi S, Lulseged S, Mengistu Y, Bhore AV, Bhosale R, Varadhrajan V, Gupte N, Sastry J, Suryavanshi N, Tripathy S, Mmiro F, Mubiru M, Onyango C, Taylor A, Musoke P, Nakabiito C, Abashawl A, Adamu R, Antelman G, Bollinger RC, Bright P, Chaudhary MA, Coberly J, Guay L, Fowler MG, Gupta A, Hassen E, Jackson JB, Moulton LH, Nayak U, Omer SB, Propper L, Ram M, Rexroad V, Ruff AJ, Shankar A, Zwerski S. Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials. Lancet. 2008 Jul 26;372(9635):300-13. doi: 10.1016/S0140-6736(08)61114-9.

    PMID: 18657709DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 11, 2003

First Posted

December 15, 2003

Study Start

February 1, 2001

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

ET(1)