NCT02166502

Brief Summary

The purpose of this study is to determine whether the current dose of nevirapine recommended in the Ontario Ministry of Health vertical transmission prevention protocol achieves therapeutic drug levels in newborn infants at high risk of HIV infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

3.2 years

First QC Date

June 5, 2014

Last Update Submit

November 17, 2015

Conditions

Human Immunodeficiency VirusHIVVertical Infection Transmission

Keywords

pediatricHIVpreventionprophylaxisnevirapine

Outcome Measures

Primary Outcomes (1)

  • Proportion of nevirapine trough (Cmin) plasma levels that are above or below the target range for prophylaxis

    Weeks 1, 2, and 4

Secondary Outcomes (5)

  • Final dose of nevirapine

    Week 4

  • Derived pharmacokinetic parameters

    Week 4

  • Association between nevirapine levels and incidence of adverse effects

    Weeks 1, 2 and 4

  • Association between patient characteristics and differences in nevirapine levels

    Baseline, Week 1, 2 and 4

  • Rate of vertical transmission of HIV

    18 months

Study Arms (1)

Nevirapine

The patients in this study are newborn infants clinically prescribed combination antiretroviral treatment with nevirapine for prevention of mother-to-child HIV transmission.

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The patients in this study are newborn infants clinically prescribed combination antiretroviral treatment with nevirapine for prevention of mother-to-child HIV transmission. These infants are routinely referred to the SickKids and CHEO HIV clinics in Toronto and Ottawa, respectively, for ongoing management. The majority of referrals are from Mount Sinai Hospital and St. Michael's Hospital in Toronto, and the Ottawa General Hospital in Ottawa.

You may qualify if:

  • Newborn infants prescribed combination antiretroviral treatment with nevirapine for prevention of mother-to-child HIV transmission. These infants are routinely referred to the Hospital for Sick Children (SickKids) and Children's Hospital of Eastern Ontario (CHEO) HIV clinics in Toronto and Ottawa, respectively, for ongoing management. The majority of referrals are from Mount Sinai Hospital and St. Michael's Hospital in Toronto, and the Ottawa General Hospital in Ottawa.
  • Voluntary informed consent by the legal guardian

You may not qualify if:

  • Infants born prior to 32 weeks gestational age;
  • Infants with life-threatening medical conditions;
  • Infants unable to take oral medication;
  • Infants born to women considered at high risk of harboring nevirapine resistance mutations in whom Kaletra (lopinavir/ritonavir) is a therapeutic option (e.g. term neonates) will be excluded and prescribed Kaletra rather than nevirapine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ari Bitnun, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 18, 2014

Study Start

February 1, 2012

Primary Completion

May 1, 2015

Study Completion

November 1, 2015

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

CA(2)