ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance

NCT04429152 | Unknown Phase 3 DMC

• 1 other identifier: EZMiM018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

This is a pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance

Conditions

HIV-1-infection

Keywords

Virological failure, first-line antiretroviral therapy; Doravirine; Delstrigo

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24

  The proportion of participants with undetectable plasma HIV-1 RNA levels at Week 24 will be recorded.

  24 weeks

Secondary Outcomes (3)

• Proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48

  At week 4, 12, 48

• Change from baseline in plasma CD4 levels at weeks 24 and 48

  At week 24, 48

• Emergence of antiretroviral resistance mutations in participants with virological failure

  48 weeks

Study Arms (1)

Doravirine

EXPERIMENTAL

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

Drug: Doravirine/Lamivudine/Tenofovir

Interventions

Doravirine/Lamivudine/Tenofovir DRUG

DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination

Also known as: Delstrigo

Doravirine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults living with HIV-1, 18 years and older
• Viral load 5000 - 60 000 copies/mL on first-line efavirenz-based antiretroviral therapy
• HIV genotype resistance test with first generation NNRTI resistance (e.g. K103N, Y181C, etc as listed in the protocol)
• CD4 \> 200 cells/uL
• Creatinine clearance \> 50 mL/min
• Body mass ≥ 35 kg.

You may not qualify if:

• Resistance to TDF on genotype (K65R)
• "Significant resistance" to doravirine, denoted by a Stanford Score ≥ 15 on genotype
• Virologic failure on any other regimen
• Women who are pregnant at the time of the screening or enrolment visits
• Active tuberculosis and/or are on anti-tuberculous 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.

Sponsors & Collaborators

• Professor Francois Venter: lead

Study Sites (3)

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2196, South Africa

RECRUITING

Sunnyside Office Park

Johannesburg, Gauteng, South Africa

NOT YET RECRUITING

Wits RHI Yeoville Clinic

Johannesburg, Gauteng, South Africa

NOT YET RECRUITING

MeSH Terms

Interventions

doravirine

Study Officials

• Simiso Sokhela, MBBCh

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simiso Sokhela, MBBCh

CONTACT

+27113585437; ssokhela@wrhi.ac.za

Bronwyn Bosch, MBBCh

CONTACT

+27113585300; bbosch@wrhi.ac.za

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Divisional Director: Ezintsha

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 12, 2020
• Study Start: February 9, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

ZA (3)