HIV-1-infectionPhase 3DORANCT04433780

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

A Phase 3 study testing Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in people with HIV-1-infection, run by Professor Francois Venter at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 49 years, women only
Conditions the study is for: HIV-1-infection
What is being tested?: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 2 sitesSouth Africa
Study dates: 4 Jan 2021to 31 Mar 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 to 49 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2196
Sunnyside Office Park
Johannesburg, Gauteng

Other trials in South Africa

About this study

Official title: 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

Read the 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
Being tested: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Keywords: Doravirine, Delstrigo, DOR/3TC/TDF, Women of reproductive potential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doravirine/Lamivudine/Tenofovir Disoproxil FumarateDrug
Also called Delstrigo
DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC

Study groups in NCT04433780
Study group	Role	What they receive
Delstrigo	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 Disoproxil Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of participants with neuropsychiatric adverse events (AEs)
The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories (dizziness, sleep disorders/ disturbances, and altered sensorium) at Week 48
Measured: 48 weeks
Changes in fasting lipids from baseline to Week 48
Changes in fasting lipids from baseline to Week 48 assessed using lipid profile blood test
Measured: 48 weeks
Changes in weight from baseline to Week 48
Changes in weight from baseline to Week 48 assessed
Measured: 48 weeks
Changes in body mass index from baseline to Week 48
Changes in body mass index from baseline to Week 48 assessed
Measured: 48 weeks
Changes in glucose from baseline to Week 48
Changes in glucose from baseline to Week 48 assessed using blood test
Measured: 48 weeks

Secondary outcomes (10)

The proportion of participants with detectable plasma HIV-1 RNA levels (≥ 50 copies/mL)
The proportion of participants with detectable plasma HIV-1 RNA levels (≥ 50 copies/mL) at weeks 24 and 48
Measured: At week 24, 48
The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories
The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories (dizziness, sleep disorders/ disturbances, and altered sensorium) at Week 24
Measured: 24 weeks
Changes in glucose from baseline to week 24
Changes in glucose from baseline to Week 24 using blood test
Measured: 24 weeks
Changes in fasting lipids from baseline to week 24
Changes in fasting lipids from baseline to Week 24 using lipid profile blood test
Measured: 24 weeks
Changes in weight and from baseline to week 24
Changes in weight from baseline to Week 24
Measured: 24 weeks
Changes in body mass index from baseline to week 24
Changes in body mass index from baseline to Week 24
Measured: 24 weeks
The proportion of infants evaluated for HIV-positive tests using HIV DNA polymerase chain reaction test (PCR)
The proportion of infants evaluated for HIV-positive tests using HIV DNA polymerase chain reaction test (PCR)
Measured: 48 weeks
Changes in quality of life from baseline
Changes in quality of life from baseline to Weeks 24 and 48 measured using a traditional clinical, validated quality of life questionairre. Higher scores mean a better outcome
Measured: At weeks 24, 48
Median adherence by each adherence measure
Median adherence by each adherence measure at Weeks 24 and 48 using a validated adherence questionairre
Measured: At weeks 24, 48
Emergence of antiretroviral resistance mutations in participants with virological failure
Evaluating 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.

4 Jan 202131 Mar 2023

First posted16 Jun 2020
Study start4 Jan 2021
Primary completion20 Feb 2023
Study completion31 Mar 2023

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: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04433780
Sponsor's protocol ID: EZMiM017
Acronym: DORA
Status last verified: Jul 2023
First submitted: 5 Jun 2020
Last updated: 3 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data that will be shared is all of the individual participant data collected during the trial, after deidentification.The data that will be shared is all of the individual participant data collected during the trial, after identification. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04433780
Acronym / sponsor ID: DORA / EZMiM017
Conditions: HIV-1-infection
Keywords: Doravirine, Delstrigo, DOR/3TC/TDF, Women of reproductive potential
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Professor Francois VenterUniversity, hospital or other
Study start: 4 Jan 2021 (actual)
Primary completion: 20 Feb 2023 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 16 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Delstrigo	Experimental	Drug: Doravirine/Lamivudine/Tenofovir Disoproxil FumarateOnce-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 to 49 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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).

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/Tenofovir Disoproxil FumarateAlso: DelstrigoDOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC	Drug	Delstrigo

Primary outcome

The proportion of participants with neuropsychiatric adverse events (AEs)
Time frame: 48 weeks
The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories (dizziness, sleep disorders/ disturbances, and altered sensorium) at Week 48
Changes in fasting lipids from baseline to Week 48
Time frame: 48 weeks
Changes in fasting lipids from baseline to Week 48 assessed using lipid profile blood test
Changes in weight from baseline to Week 48
Time frame: 48 weeks
Changes in weight from baseline to Week 48 assessed
Changes in body mass index from baseline to Week 48
Time frame: 48 weeks
Changes in body mass index from baseline to Week 48 assessed
Changes in glucose from baseline to Week 48
Time frame: 48 weeks
Changes in glucose from baseline to Week 48 assessed using blood test

10 secondary outcomes

The proportion of participants with detectable plasma HIV-1 RNA levels (≥ 50 copies/mL)
Time frame: At week 24, 48
The proportion of participants with neuropsychiatric adverse events (AEs) in 3 pre-specified categories
Time frame: 24 weeks
Changes in glucose from baseline to week 24
Time frame: 24 weeks
Changes in fasting lipids from baseline to week 24
Time frame: 24 weeks
Changes in weight and from baseline to week 24
Time frame: 24 weeks
Changes in body mass index from baseline to week 24
Time frame: 24 weeks
The proportion of infants evaluated for HIV-positive tests using HIV DNA polymerase chain reaction test (PCR)
Time frame: 48 weeks
Changes in quality of life from baseline
Time frame: At weeks 24, 48
Median adherence by each adherence measure
Time frame: At weeks 24, 48
Emergence of antiretroviral resistance mutations in participants with virological failure
Time frame: 48 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
Individual participant dataSharing planned: Yes. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.The data that will be shared is all of the individual participant data collected during the trial, after identification. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.

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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 principal investigator

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

2 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 Disoproxil Fumarate in people with HIV-1-infection, run by Professor Francois Venter at 2 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of participants with neuropsychiatric adverse events (AEs) (time frame: 48 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433780.

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 3 Aug 2023.