HIV-1 InfectionPhase 3DRIVE-SHIFTNCT02397096

Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)

A Phase 3 study testing Doravirine, Tenofovir, Lamivudine, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor and Baseline regimen of cobicistat-boosted elvitegravir 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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: Doravirine, Tenofovir, Lamivudine, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor and Baseline regimen of cobicistat-boosted elvitegravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 673 participants
Where: No sites listed yet
Study dates: 9 Jun 2015to 5 Sep 2023
Phase: Phase 3
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

Have plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) levels below the limit of quantification (BLoQ) (<40 copies/mL by the Abbott RealTime HIV-1 Assay as determined by the central laboratory) at the screening visit.
Receiving antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 Nucleoside Reverse Transcriptase Inhibitor (NRTIs) (and no other antiretroviral therapy) continuously for >= 6 months.
Receiving first or second retroviral regimen (participants receiving a NNRTI at Screening must be on their first retroviral regimen)
No history of using an experimental NNRTI
Has a genotype prior to starting his/her initial antiretroviral regimen and no known resistance to any of the study agents
Not receiving lipid lowering therapy or on a stable dose of lipid lowering therapy at the time of enrollment

Show all 12Show fewer

Has the following laboratory values at screening within 30 days prior to the treatment phase of this study: Alkaline phosphatase ≤ 3.0 x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 5.0 x ULN, and Hemoglobin ≥9.0 g/dL (if female) or ≥10.0 g/dL (if male)
Has a calculated creatinine clearance at the time of screening ≥ 50 mL/min, based on the Cockcroft-Gault equation
Male or female participant not of reproductive potential or, if of reproductive potential, agrees to avoid becoming pregnant or impregnating a partner while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: 1) practice abstinence from heterosexual activity, or 2) use acceptable contraception during heterosexual activity
For inclusion in Study Extension 1 (optional): completed the Week 48 visit; considered to have derived benefit from study participation up to Week 48; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
For inclusion in Study Extension 2 (optional): completed the Week 144 visit; considered to have derived benefit from study participation up to Week 144; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
For inclusion in Study Extension 3 (optional): completed the Week 240 visit; considered to have derived benefit from study participation up to Week 240; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug

Who cannot join

Uses recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence
Received treatment for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 such as adefovir, emtricitabine, lamivudine, or tenofovir
Has documented or known resistance to study drugs including doravirine, lamivudine, and/or tenofovir
Participated in a study with an investigational compound or device within 30 days or anticipates doing so during the course of this study
Used systemic immunosuppressive therapy or immune modulators within 30 days or anticipates needing them during the course of this study (short courses of corticosteroids will be allowed)
Current, active diagnosis of acute hepatitis due to any cause (participants with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic function)

Show all 9Show fewer

Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte score >9
Pregnant, breastfeeding, or expecting to conceive at any time during the study
Female and is expecting to donate eggs or male and is expecting to donate sperm during the study

About this study

Official title: A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to doravirine, tenofovir, lamivudine will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study results will be based on the first 48 weeks of this ongoing study.

Read the detailed description

Three optional study extensions are planned. Study Extension 1 will evaluate safety of the switch to doravirine, tenofovir, lamivudine for an additional 2 years beyond the Base Study. Study Extensions 2 and 3 will evaluate safety of the switch to doravirine, tenofovir, lamivudine until doravirine, tenofovir, lamivudine becomes locally available, or 4 years beyond Study Extension 1, whichever comes first.

Conditions: HIV-1 Infection
Being tested: Doravirine, Tenofovir, Lamivudine, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Baseline regimen of cobicistat-boosted elvitegravir, Baseline regimen of a non-nucleoside reverse transcriptase inhibitor, Baseline regimen of two nucleoside reverse transcriptase inhibitors

What participants receive

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

Doravirine, Tenofovir, LamivudineDrug
Also called Doravirine (PIFELTRO™), Doravirine/Lamivudine/Tenofovir disoproxil fumarate (DELSTRIGO™), MK-1439A
Single tablet containing MK-1439 (doravirine) 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg
Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitorDrug
Baseline regimen of antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) administered according to the product circular
Baseline regimen of cobicistat-boosted elvitegravirDrug
Baseline regimen of antiretroviral therapy with cobicistat-boosted elvitegravir administered according to the product circular
Baseline regimen of a non-nucleoside reverse transcriptase inhibitorDrug
Baseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular
Baseline regimen of two nucleoside reverse transcriptase inhibitorsDrug
Baseline regimen of antiretroviral therapy with two NRTIs administered according to the product circular

Study groups in NCT02397096
Study group	Role	What they receive
Immediate Switch to Doravirine, Tenofovir, Lamivudine	Experimental	Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to doravirine, tenofovir, lamivudine single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions Receives: Drug: Doravirine, Tenofovir, Lamivudine; Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor; Drug: Baseline regimen of cobicistat-boosted elvitegravir; Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor; Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitors
Delayed Switch to Doravirine, Tenofovir, Lamivudine	Active comparator	Participants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to doravirine, tenofovir, lamivudine single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions Receives: Drug: Doravirine, Tenofovir, Lamivudine; Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor; Drug: Baseline regimen of cobicistat-boosted elvitegravir; Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor; Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitors

What is being measured

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

Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Measured: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24

Secondary outcomes (11)

Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
Measured: Baseline and Week 24
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy.
Measured: Baseline and Week 24
Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Measured: Week 24
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Measured: Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
Measured: Baseline and Week 24
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.
Measured: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups.
Measured: Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants With HIV-1 RNA >=50 Copies/mL
The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach.
Measured: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to week 24
Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed.
Measured: Up to 24 weeks
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Week 24

Timeline

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

9 Jun 20155 Sep 2023

First posted24 Mar 2015 (estimated)
Study start9 Jun 2015
Primary completion22 Feb 2018
Study completion5 Sep 2023

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 (5)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 673 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02397096
Sponsor's protocol ID: 1439A-024
Other IDs: MK-1439A-024, 2014-005550-18, 2014
Acronym: DRIVE-SHIFT
Status last verified: Nov 2024
First submitted: 18 Mar 2015
Last updated: 20 Nov 2024
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

Orkin C, Koethe JR, Kumar PN, Sklar P, Xu ZJ, Plank RM, Greaves W, Lahoulou R. Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen. Open Forum Infect Dis. 2025 Nov 20;12(11):ofaf639. doi: 10.1093/ofid/ofaf639. eCollection 2025 Nov.
PubMed 41280318
Walmsley SL, Kumar PN, Orkin C, Thompson M, Squires K, Xu ZJ, Greaves W, Plank RM, Whiteside Y, Lahoulou R. Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials. Open Forum Infect Dis. 2025 Jul 16;12(7):ofaf356. doi: 10.1093/ofid/ofaf356. eCollection 2025 Jul.
PubMed 40672760
Kumar P, Johnson M, Molina JM, Rizzardini G, Cahn P, Bickel M, Wan H, Xu ZJ, Morais C, Sklar P, Greaves W; DRIVE-SHIFT Study Group. Brief Report: Switching to DOR/3TC/TDF Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):801-805. doi: 10.1097/QAI.0000000000002642.
PubMed 33633036
Vaddady P, Kandala B, Yee KL. Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00590-20. doi: 10.1128/AAC.00590-20. Print 2020 Oct 20.
PubMed 32868326
Johnson M, Kumar P, Molina JM, Rizzardini G, Cahn P, Bickel M, Mallolas J, Zhou Y, Morais C, Kumar S, Sklar P, Hanna GJ, Hwang C, Greaves W; DRIVE-SHIFT Study Group. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2019 Aug 1;81(4):463-472. doi: 10.1097/QAI.0000000000002056.
PubMed 30985556

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

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
ClinicalTrials.gov ID: NCT02397096
Acronym / sponsor ID: DRIVE-SHIFT / 1439A-024
Conditions: HIV-1 Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 673 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 9 Jun 2015 (actual)
Primary completion: 22 Feb 2018 (actual)
Study completion: 5 Sep 2023 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 3 Apr 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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate Switch to Doravirine, Tenofovir, Lamivudine	Experimental	Drug: Doravirine, Tenofovir, Lamivudine, Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Drug: Baseline regimen of cobicistat-boosted elvitegravir, Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor, Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitorsParticipants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a non nucleoside reverse transcriptase inhibitor (NNRTI) (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will switch on Day 1 to doravirine, tenofovir, lamivudine single tablet by mouth once daily for 48 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions
Delayed Switch to Doravirine, Tenofovir, Lamivudine	Active comparator	Drug: Doravirine, Tenofovir, Lamivudine, Drug: Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Drug: Baseline regimen of cobicistat-boosted elvitegravir, Drug: Baseline regimen of a non-nucleoside reverse transcriptase inhibitor, Drug: Baseline regimen of two nucleoside reverse transcriptase inhibitorsParticipants receiving continuous antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 NRTIs for >=6 months with undetectable HIV-1 RNA will continue on this therapy until Week 24, at which time they will switch to doravirine, tenofovir, lamivudine single tablet by mouth once daily for 24 weeks in the Base Study and, optionally, for up to an additional 6 years in the Study Extensions

Who may qualify

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

Key inclusion criteria (12 listed)

Have plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) levels below the limit of quantification (BLoQ) (<40 copies/mL by the Abbott RealTime HIV-1 Assay as determined by the central laboratory) at the screening visit.
Receiving antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2 Nucleoside Reverse Transcriptase Inhibitor (NRTIs) (and no other antiretroviral therapy) continuously for >= 6 months.
Receiving first or second retroviral regimen (participants receiving a NNRTI at Screening must be on their first retroviral regimen)
No history of using an experimental NNRTI
Has a genotype prior to starting his/her initial antiretroviral regimen and no known resistance to any of the study agents

Key exclusion criteria (9 listed)

Uses recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence
Received treatment for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 such as adefovir, emtricitabine, lamivudine, or tenofovir
Has documented or known resistance to study drugs including doravirine, lamivudine, and/or tenofovir
Participated in a study with an investigational compound or device within 30 days or anticipates doing so during the course of this study
Used systemic immunosuppressive therapy or immune modulators within 30 days or anticipates needing them during the course of this study (short courses of corticosteroids will be allowed)

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, Tenofovir, LamivudineAlso: Doravirine (PIFELTRO™), Doravirine/Lamivudine/Tenofovir disoproxil fumarate (DELSTRIGO™), MK-1439ASingle tablet containing MK-1439 (doravirine) 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg	Drug	Delayed Switch to Doravirine, Tenofovir, Lamivudine, Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitorBaseline regimen of antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) administered according to the product circular	Drug	Delayed Switch to Doravirine, Tenofovir, Lamivudine, Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of cobicistat-boosted elvitegravirBaseline regimen of antiretroviral therapy with cobicistat-boosted elvitegravir administered according to the product circular	Drug	Delayed Switch to Doravirine, Tenofovir, Lamivudine, Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of a non-nucleoside reverse transcriptase inhibitorBaseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular	Drug	Delayed Switch to Doravirine, Tenofovir, Lamivudine, Immediate Switch to Doravirine, Tenofovir, Lamivudine
Baseline regimen of two nucleoside reverse transcriptase inhibitorsBaseline regimen of antiretroviral therapy with two NRTIs administered according to the product circular	Drug	Delayed Switch to Doravirine, Tenofovir, Lamivudine, Immediate Switch to Doravirine, Tenofovir, Lamivudine

Primary outcome

Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Time frame: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason.

11 secondary outcomes

Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and Week 24
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: Baseline and Week 24
Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
Time frame: Week 24
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
Time frame: Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
Time frame: Baseline and Week 24
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
Time frame: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
Time frame: Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants With HIV-1 RNA >=50 Copies/mL
Time frame: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to week 24
Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
Time frame: Up to 24 weeks
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
Time frame: Up to Week 24

Results and safety

Results posted to the registry on 3 Apr 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
Immediate Switch Group (ISG)	450	427
Delayed Switch Group (DSG)	223	209

Primary outcome: Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL

Time frame: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24. Number. Unit: Percentage of Participants

Measure	Immediate Switch Group (ISG) n = 447	Delayed Switch Group (DSG) n = 223
Value	90.8	94.6

Immediate Switch Group (ISG) vs Delayed Switch Group (DSG): Treatment Difference: -3.784 (95% CI -7.877 to 0.310)

Population analysed: All randomized participants who received at least 1 dose of study drug.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to ~338 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISG Base Study Weeks 0-24	13 of 447 (2.9%)	100 of 447 (22.4%)	1 of 450
DSG Base Study Weeks 0-24	8 of 223 (3.6%)	28 of 223 (12.6%)	0 of 223
ISG Base Study Weeks 24-48	11 of 427 (2.6%)	63 of 427 (14.8%)	0 of 427
DSG Base Study Weeks 24-48	4 of 209 (1.9%)	33 of 209 (15.8%)	0 of 209
ISG Study Extension 1	37 of 398 (9.3%)	107 of 398 (26.9%)	1 of 398
DSG Study Extension 1	13 of 202 (6.4%)	57 of 202 (28.2%)	0 of 202
ISG Study Extension 2	13 of 303 (4.3%)	24 of 303 (7.9%)	3 of 303
DSG Study Extension 2	7 of 154 (4.5%)	11 of 154 (7.1%)	0 of 154
ISG Study Extension 3	3 of 84 (3.6%)	9 of 84 (10.7%)	0 of 84
DSG Study Extension 3	1 of 43 (2.3%)	3 of 43 (7%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41280318Orkin C, Koethe JR, Kumar PN, Sklar P, Xu ZJ, Plank RM, Greaves W, Lahoulou R. Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen. Open Forum Infect Dis. 2025 Nov 20;12(11):ofaf639. doi: 10.1093/ofid/ofaf639. eCollection 2025 Nov.
Derived from this study: PubMed 40672760Walmsley SL, Kumar PN, Orkin C, Thompson M, Squires K, Xu ZJ, Greaves W, Plank RM, Whiteside Y, Lahoulou R. Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials. Open Forum Infect Dis. 2025 Jul 16;12(7):ofaf356. doi: 10.1093/ofid/ofaf356. eCollection 2025 Jul.
Derived from this study: PubMed 33633036Kumar P, Johnson M, Molina JM, Rizzardini G, Cahn P, Bickel M, Wan H, Xu ZJ, Morais C, Sklar P, Greaves W; DRIVE-SHIFT Study Group. Brief Report: Switching to DOR/3TC/TDF Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):801-805. doi: 10.1097/QAI.0000000000002642.
Derived from this study: PubMed 32868326Vaddady P, Kandala B, Yee KL. Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00590-20. doi: 10.1128/AAC.00590-20. Print 2020 Oct 20.
Derived from this study: PubMed 30985556Johnson M, Kumar P, Molina JM, Rizzardini G, Cahn P, Bickel M, Mallolas J, Zhou Y, Morais C, Kumar S, Sklar P, Hanna GJ, Hwang C, Greaves W; DRIVE-SHIFT Study Group. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2019 Aug 1;81(4):463-472. doi: 10.1097/QAI.0000000000002056.
Merck Clinical Trials InformationLink provided by the sponsor.
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?

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 12 inclusion and 9 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 20 Nov 2024. 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 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?

Yes. Results are posted in the registry (first posted 3 Apr 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 Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL (time frame: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24). 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 NCT02397096, which also lists 5 linked publications.

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 20 Nov 2024.