Status:
COMPLETED
DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV
Lead Sponsor:
Professor Francois Venter
Conditions:
HIV-1-infection
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief 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 pote...
Detailed 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) a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04433780
Start Date
January 4 2021
End Date
March 31 2023
Last Update
August 3 2023
Active Locations (2)
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1
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa, 2196
2
Sunnyside Office Park
Johannesburg, Gauteng, South Africa