Status:

COMPLETED

A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation

Lead Sponsor:

Adeniyi Olagunju

Collaborating Sponsors:

University of Liverpool

Obafemi Awolowo University Teaching Hospital

Conditions:

HIV

Pregnancy

Eligibility:

FEMALE

18+ years

Brief Summary

Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the ...

Detailed Description

Study design: This is an observational study that will be conducted in two phases. In the preliminary phase, associations between selected SNPs in drug disposition genes and mid-dose plasma and breast...

Eligibility Criteria

Inclusion

  • HIV positive
  • breastfeeding
  • enrolled in PMTCT programme
  • started efavirenz- or nevirapine-containing regimen during pregnancy

Exclusion

  • exclusive replacement feeding
  • mixed feeding before 6 months
  • severe maternal or infant illness
  • maternal or infant treatment with other drugs or herbal medication with known or uncertain interaction with study drug

Key Trial Info

Start Date :

December 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2013

Estimated Enrollment :

460 Patients enrolled

Trial Details

Trial ID

NCT02269462

Start Date

December 1 2012

End Date

November 1 2013

Last Update

September 6 2017

Active Locations (3)

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Page 1 of 1 (3 locations)

1

St Monica's Hospital

Adikpo, Benue State, Nigeria

2

Bishop Murray Medical Centre

Makurdi, Benue State, Nigeria

3

St Mary's Hospital

Okpoga, Benue State, Nigeria