HIV-1-infectionPhase 3ADORENCT04429152
ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance
A Phase 3 study testing Doravirine/Lamivudine/Tenofovir in people with HIV-1-infection, run by Professor Francois Venter at 3 sites in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Doravirine/Lamivudine/Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 9 Feb 2021to Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites, 3 recruiting
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2196
Natasha Arulappan, +27113585542, gakpomiemie@wrhi.ac.za
Nonkululeko Mashabane, BPharm, +27113585543
- Not yet recruiting
Sunnyside Office Park
Johannesburg, Gauteng
Bronwyn Bosch, MBBCh, +27113585300, bbosch@wrhi.ac.za
Godspower Akpomiemie, MPH, +2711358 5370, gakpomiemie@wrhi.ac.za
- Not yet recruiting
Wits RHI Yeoville Clinic
Johannesburg, Gauteng
Simiso Sokhela, MBBCh, +27113585500, ssokhela@wrhi.ac.za
Nonkululeko Mashabane, BPharm, +27113585543, nmashabane@wrhi.ac.za
About this study
Official title: ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistance
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
Read the detailed description
This is a single-arm, phase 3 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.
Approximately 25 male and female participants 18 years and older infected with HIV-1 and experiencing virological failure on efavirenz-based ART 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
- Being tested
- Doravirine/Lamivudine/Tenofovir
- Keywords
- Virological failure, first-line antiretroviral therapy, Doravirine, Delstrigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doravirine/Lamivudine/TenofovirDrug
Also called Delstrigo
DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination
| Study group | Role | What they receive |
|---|---|---|
| Doravirine | Experimental | Once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). Receives: Drug: Doravirine/Lamivudine/Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
Proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48
Evaluation of viral suppression by recording the proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48
Measured: At week 4, 12, 48
Change from baseline in plasma CD4 levels at weeks 24 and 48
Evaluation of changes in CD4 count from baseline recorded at weeks 24 and 48.
Measured: At week 24, 48
Emergence of antiretroviral resistance mutations in participants with virological failure
Evaluation of the number of antiretroviral resistance mutations that emerge in participants with virological failure
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start9 Feb 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Francois Venter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Simiso Sokhela, MBBCh, Principal investigator, Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429152
- Sponsor's protocol ID
- EZMiM018
- Acronym
- ADORE
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistance
- ClinicalTrials.gov ID
- NCT04429152
- Acronym / sponsor ID
- ADORE / EZMiM018
- Conditions
- HIV-1-infection
- Keywords
- Virological failure, first-line antiretroviral therapy, Doravirine, Delstrigo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Professor Francois VenterUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a single-arm, phase 3 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.
Approximately 25 male and female participants 18 years and older infected with HIV-1 and experiencing virological failure on efavirenz-based ART 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doravirine | Experimental | Drug: Doravirine/Lamivudine/TenofovirOnce-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doravirine/Lamivudine/TenofovirAlso: DelstrigoDOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination | Drug | Doravirine |
Primary outcome
Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24
Time frame: 24 weeks
The proportion of participants with undetectable plasma HIV-1 RNA levels at Week 24 will be recorded.
3 secondary outcomes
Proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48
Time frame: At week 4, 12, 48
Change from baseline in plasma CD4 levels at weeks 24 and 48
Time frame: At week 24, 48
Emergence of antiretroviral resistance mutations in participants with virological failure
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simiso Sokhela, MBBCh principal investigator
Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doravirine/Lamivudine/Tenofovir in people with HIV-1-infection, run by Professor Francois Venter at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simiso Sokhela, MBBCh (+27113585437, ssokhela@wrhi.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.