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

NCT ID: NCT04433780

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2023-03-31

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 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.

Conditions

HIV-1-infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Delstrigo

Once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF).

Group Type: EXPERIMENTAL

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

Intervention Type: DRUG

DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC

Interventions

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC

Intervention Type: DRUG

Other Intervention Names

Delstrigo

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Professor Francois Venter

OTHER

Sponsor Role: lead

Responsible Party

Professor Francois Venter

Divisional Director of Ezintsha

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Simiso Sokhela

Role: PRINCIPAL_INVESTIGATOR

Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)

Locations

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa

Sunnyside Office Park

Johannesburg, Gauteng, South Africa

Countries

South Africa

Other Identifiers

EZMiM017

Identifier Type: -

Identifier Source: org_study_id