DORA: The Safety of Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV in South Africa

  • STATUS
    Recruiting
  • End date
    Dec 26, 2021
  • participants needed
    100
  • sponsor
    Willem Daniel Francois Venter
Updated on 26 January 2021

Summary

This is a pilot study investigating the safety of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy on metabolic and neuropsychiatric outcomes.

Description

This is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the safety of of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy. The metabolic and neuropsychiatric outcomes among women (and their infants) in a representative African female population of reproductive potential will be investigated.

Approximately 100 women aged between 18 and 49 years old will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study visits from Week 4 to Week 36, and an end of study visit at Week 48.

Details
Condition HIV-1-infection
Treatment Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Clinical Study IdentifierNCT04433780
SponsorWillem Daniel Francois Venter
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Females, aged 18-49 years and 40 kg
On a first-line EFV or DTG-containing regimen for at least six months and not more than 3 years
Plasma HIV-1 RNA < 50 copies/mL in last 60 days
Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula)
Baseline weight measurement available at ART initiation

Exclusion Criteria

Virological failure on any other regimen
Women who are pregnant at the time of the screening or enrolment visits or have had a pregnancy gestation 28 weeks in the preceding 2 years
Active tuberculosis and/or are on antituberculosis therapy at the time of the screening or enrolment visits
Taking (and cannot discontinue) prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period (see potential drug interactions section for list)
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