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DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV | Clinical Trials | Clareo Health

COMPLETEDPHASE3

DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV

A Single Arm, Phase 3 Study, Exploring the Safety of Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV, a Pilot Switch Study Strategy in South Africa

NCT04433780•Professor Francois Venter

View on ClinicalTrials.gov

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.

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) 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.

Eligibility

Age

18 - 49 years

Sex

FEMALE

Healthy Volunteers

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).

Locations (2)

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa

Sunnyside Office Park

Johannesburg, Gauteng, South Africa

Key Dates

Start Date

January 4, 2021

Primary Completion Date

February 20, 2023

Completion Date

March 31, 2023

Last Updated

August 3, 2023

Enrollment

133

ACTUAL participants

Conditions

HIV-1-infection

Interventions

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

DRUG

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

NCT07055451

HIV-1-infection

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RECRUITINGNA

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703

DepressionHIV-1-infection+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV

Inclusion Criteria

Exclusion Criteria

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