drugset / Trial / NCT04433780

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

NCT04433780

Phase 3 Completed 133 enrolled Professor Francois Venter
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-01-04
Primary completion
2023-02-20
Completion
2023-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Doravirine Small molecule 100 mg
Subject Lamivudine Other / unclassified 300 mg
Subject Tenofovir disoproxil fumarate Small molecule 300 mg