HIV-1 InfectionPhase 2DRIVE BEYONDNCT02629822

Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)

A Phase 2 study testing Doravirine/lamivudine/tenofovir disoproxil fumarate in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC.

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

The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in… 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 disoproxil fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: 14 Jan 2016to 28 Oct 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment.
Is naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A.
Is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
Is highly unlikely to become pregnant or to impregnate a partner

Who cannot join

Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
Has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir)
Has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
Requires or anticipates requiring any of the prohibited medications

Show all 11Show fewer

Has significant hypersensitivity or other contraindication to any of the components of the study drug
Has a current (active) diagnosis of acute hepatitis due to any cause
Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9
Is pregnant, breastfeeding, or expecting to conceive
Is female and expecting to donate eggs, or is male and is expecting to donate sperm at any time during the study

About this study

Official title: A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations

Read the detailed description

This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).

Conditions: HIV-1 Infection
Being tested: Doravirine/lamivudine/tenofovir disoproxil fumarate

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 MK-1439A, DELSTRIGO™
FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.

Study groups in NCT02629822
Study group	Role	What they receive
DOR/3TC/TDF	Experimental	Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study. Receives: Drug: Doravirine/lamivudine/tenofovir disoproxil fumarate

What is being measured

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

Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit.
Measured: Week 48
Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measured: Up to Week 48
Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measured: Up to Week 48
Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measured: Up to Week 96
Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Measured: Up to Week 96

Secondary outcomes (6)

Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit.
Measured: Week 96
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
Measured: Week 48
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
Measured: Week 96
Change From Baseline in CD4 Cell Count at Week 48
The change from baseline in CD4 cell count at Week 48 was calculated.
Measured: Baseline (Day 1) and Week 48
Change From Baseline in CD4 Cell Count at Week 96
The change from baseline in CD4 cell count at Week 96 was calculated.
Measured: Baseline (Day 1) and Week 96
Time to Loss of Virologic Response
The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement.
Measured: Up to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 201628 Oct 2020

First posted14 Dec 2015 (estimated)
Study start14 Jan 2016
Primary completion28 Nov 2018
Study completion28 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02629822
Sponsor's protocol ID: 1439A-030
Other IDs: 2015-003616-20, MK-1439A-030, 2015
Acronym: DRIVE BEYOND
Status last verified: Oct 2021
First submitted: 10 Dec 2015
Last updated: 26 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Wong A, Goldstein D, Mallolas J, DeJesus E, Johnson M, Molina JM, Pozniak A, Rodgers A, Teal V, Hepler D, Kumar S, Sklar P, Hanna GJ, Hwang C, Badshah C, Teppler H. Efficacy and Safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) in Treatment-Naive Adults With HIV-1 and Transmitted Nonnucleoside Reverse Transcriptase Inhibitor Resistance Mutations. J Acquir Immune Defic Syndr. 2019 Dec 1;82(4):e47-e49. doi: 10.1097/QAI.0000000000002153.
PubMed 31425317

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations
ClinicalTrials.gov ID: NCT02629822
Acronym / sponsor ID: DRIVE BEYOND / 1439A-030
Conditions: HIV-1 Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 14 Jan 2016 (actual)
Primary completion: 28 Nov 2018 (actual)
Study completion: 28 Oct 2020 (actual)
First posted: 14 Dec 2015 (estimated)
Results: Posted 26 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).

Study design

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

Arm	Type	Receives
DOR/3TC/TDF	Experimental	Drug: Doravirine/lamivudine/tenofovir disoproxil fumarateTreatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment.
Is naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A.
Is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
Is highly unlikely to become pregnant or to impregnate a partner

Key exclusion criteria (11 listed)

Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
Has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir)
Has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.

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: MK-1439A, DELSTRIGO™FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.	Drug	DOR/3TC/TDF

Primary outcome

Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
Time frame: Week 48
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit.
Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
Time frame: Up to Week 48
The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
Time frame: Up to Week 48
The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
Time frame: Up to Week 96
The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
Time frame: Up to Week 96
The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.

6 secondary outcomes

Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
Time frame: Week 96
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
Time frame: Week 48
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
Time frame: Week 96
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline (Day 1) and Week 96
Time to Loss of Virologic Response
Time frame: Up to Week 96

Results and safety

Results posted to the registry on 26 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DOR/3TC/TDF	10	7

Primary outcome: Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48

Time frame: Week 48. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	DOR/3TC/TDF n = 8
Value	100.0 (63.1 to 100.0)

Population analysed: All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations.

Primary outcome: Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48

Time frame: Up to Week 48. Number. Unit: Percentage of Participants

Measure	DOR/3TC/TDF n = 10
Value	90.0

Population analysed: All participants who received ≥1 dose of MK-1439A.

Primary outcome: Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.

Time frame: Up to Week 48. Number. Unit: Percentage of Participants

Measure	DOR/3TC/TDF n = 10
Value	0.0

Population analysed: All participants who received ≥1 dose of MK-1439A.

Primary outcome: Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96

Time frame: Up to Week 96. Number. Unit: Percentage of Participants

Measure	DOR/3TC/TDF n = 10
Value	90.0

Population analysed: All participants who received ≥1 dose of MK-1439A.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 192 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DOR/3TC/TDF Base Study: Day 1 to Week 96	1 of 10 (10%)	9 of 10 (90%)	0 of 10
DOR/3TC/TDF Study Extension: Week 97 to Week 192	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31425317Wong A, Goldstein D, Mallolas J, DeJesus E, Johnson M, Molina JM, Pozniak A, Rodgers A, Teal V, Hepler D, Kumar S, Sklar P, Hanna GJ, Hwang C, Badshah C, Teppler H. Efficacy and Safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) in Treatment-Naive Adults With HIV-1 and Transmitted Nonnucleoside Reverse Transcriptase Inhibitor Resistance Mutations. J Acquir Immune Defic Syndr. 2019 Dec 1;82(4):e47-e49. doi: 10.1097/QAI.0000000000002153.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doravirine/lamivudine/tenofovir disoproxil fumarate in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC.

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 11 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48 (time frame: Week 48). 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 NCT02629822, which also lists 1 linked publication.

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 26 Oct 2021.