HivPhase 4D2ARLINGNCT04549467
Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test
A Phase 4 study testing Lamivudine 300 MG and Emtricitabine / Tenofovir Disoproxil Pill in people with Hiv and HIV-1-infection, run by Fundacion IDEAA at 1 site in Argentina.
Trial summary
The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, HIV-1-infection
- What is being tested?
- Lamivudine 300 MG and Emtricitabine / Tenofovir Disoproxil Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteArgentina
- Study dates
- 17 Nov 2020to 30 Sep 2023
- Phase
- Phase 4
- 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
- Subject should be antiretroviral naïve (defined as <=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection).
- Age ≥ 18 years
- Screening plasma HIV-1 RNA ≥1000 c/mL
- CD4 cell count nadir: any value
- Effective contraception for women of childbearing potential.
- Informed consent form signed by patient and investigator
Who cannot join
- History of suicide ideation, intention or action.
- Evidence of HBV infection based on the results of testing at Screening* for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (antiHBs or HBsAb), and HBV DNA as follows: Subjects positive for HBsAg are excluded; Subjects negative for anti-HBs and HBsAg but positive for anti-HBc and positive for HBV DNA are excluded.
- Anticipated need for any HCV therapy during the first 48 weeks of the study.
- Acute symptomatic HIV Infection.
- Any active Opportunistic Infection (category C, CDC 2014).
- Current pregnancy or breastfeeding.
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- No effective contraception for the women of childbearing.
- Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.
- ALT (Alanine Aminotransferase) ≥ 5 x upper limit of normal value (ULN) or AST (Aspartate Aminotransferase) ≥ 3 x ULN and bilirubinemia ≥ 1.5 x ULN (with 35% direct bilirubinemia).
- Unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice).
- Creatinine clearance of <50 mL/min/1.73 m2 (Cockroft-Gault method).
- History or presence of allergy to the trial drugs or their components.
- Severe hepatic insufficiency (Child Pugh Class C).
- Any available historical resistance test result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults Without Baseline Genotyping Test (D2ARLING Study)
The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.
Read the detailed description
This is a 48-week, Phase IV, randomized, open-label, to assess the non-inferior antiviral activity (VL < 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV1 naïve adult patients without baseline GT available at Day 1 visit. Subjects will be stratified by screening HIV-1 RNA (≤100,000 c/mL or >100,000 c/mL) and Screening CD4+ cell count (≤ or >200 cells/mm3).
The study will comprise:
- a 28-day Screening Phase (which may be extended to 35 days to allow receipt of all Screening assessment results).
- an Open-label Randomized Phase (Day 1 to Week 48).
Approximately 200 HIV-1 naïve adult patients will be randomized 1:1 to receive 2DR DTG+3TC versus 3DR TDF/FTC + DTG for 48 weeks.
- Conditions
- Hiv, HIV-1-infection
- Being tested
- Lamivudine 300 MG, Emtricitabine / Tenofovir Disoproxil Pill
- Keywords
- hiv, antiretroviral treatment, dolutegravir, dual therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine 300 MGDrug
Also called 3TC, dolutegravir
Experimental arm
Emtricitabine / Tenofovir Disoproxil PillDrug
Also called truvada, dolutegravir
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir + lamivudine | Experimental | Dolutegravir 50 mg, 1 tablet QD plus lamivudine 300 mg, 1 tablet QD Receives: Drug: Lamivudine 300 MG |
| Dolutegravir + emtricitabine/tenofovir (FTC/TDF) | Active comparator | Dolutegravir 50 mg, 1 tablet QD plus FTC/TDF 200/300 mg, 1 coformulated tablet QD Receives: Drug: Emtricitabine / Tenofovir Disoproxil Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Efficacy
To demonstrate the non-inferior antiviral activity (VL < 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV-1 naïve adult patients without baseline genotypic resistance testing available. Endpoint: Proportion of subjects with plasma HIV-1 RNA <50 copies/mL (c/mL) at Week 48 using the FDA Snapshot algorithm [Missing, Switch or Discontinuation = Failure (MSD=F)] for the intent-to-treat exposed (ITT-E) population.
Measured: 48 weeks
Secondary outcomes (2)
Genetic barrier
To assess the selection / emergence of viral resistance in subjects meeting confirmed virologic withdrawal (CVW) criteria. Endpoint: incidence of treatment-emergent genotypic resistance to DTG and 3TC or TDF/FTC in subjects meeting CVW criteria.
Measured: 48 weeks
Efficacy in presence of any major resistanceassociated mutation al baseline
To evaluate the antiviral activity of DTG + 3TC compared to DTG + TDF/FTC over time in patients with pre-existing viral resistance based on the presence of any major resistanceassociated mutation (IAS-USA 2019). Endpoint: Proportion of subjects with plasma HIV-1 RNA <50 copies/mL (c/mL) at Week 48 using the FDA Snapshot algorithm and The proportion of participants with HIV-1 RNA <50 or <200 copies/mL using the observed algorithm (excluding participants with missing data) in patients with pre-existing viral resistance based on the presence of any major resistance-associated mutation (IAS-USA 2019).
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 posted16 Sep 2020
- Study start17 Nov 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion IDEAA
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Ezequiel Cordova, MD, Principal investigator, Fundacion IDEAA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549467
- Sponsor's protocol ID
- IDEAA 002
- Acronym
- D2ARLING
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cordova E, Hernandez Rendon J, Mingrone V, Martin P, Arevalo Calderon G, Seleme S, Ballivian J, Porteiro N. Efficacy of dolutegravir plus lamivudine in treatment-naive people living with HIV without baseline drug-resistance testing available (D2ARLING): 48-week results of a phase 4, randomised, open-label, non-inferiority trial. Lancet HIV. 2025 Feb;12(2):e95-e104. doi: 10.1016/S2352-3018(24)00294-7. Epub 2025 Jan 15.
PubMed 39826566
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults Without Baseline Genotyping Test (D2ARLING Study)
- ClinicalTrials.gov ID
- NCT04549467
- Acronym / sponsor ID
- D2ARLING / IDEAA 002
- Conditions
- Hiv, HIV-1-infection
- Keywords
- hiv, antiretroviral treatment, dolutegravir, dual therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Fundacion IDEAAUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 16 Sep 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.
The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.
Detailed description
This is a 48-week, Phase IV, randomized, open-label, to assess the non-inferior antiviral activity (VL < 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV1 naïve adult patients without baseline GT available at Day 1 visit. Subjects will be stratified by screening HIV-1 RNA (≤100,000 c/mL or >100,000 c/mL) and Screening CD4+ cell count (≤ or >200 cells/mm3).
The study will comprise:
- a 28-day Screening Phase (which may be extended to 35 days to allow receipt of all Screening assessment results).
- an Open-label Randomized Phase (Day 1 to Week 48).
Approximately 200 HIV-1 naïve adult patients will be randomized 1:1 to receive 2DR DTG+3TC versus 3DR TDF/FTC + DTG for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir + lamivudine | Experimental | Drug: Lamivudine 300 MGDolutegravir 50 mg, 1 tablet QD plus lamivudine 300 mg, 1 tablet QD |
| Dolutegravir + emtricitabine/tenofovir (FTC/TDF) | Active comparator | Drug: Emtricitabine / Tenofovir Disoproxil PillDolutegravir 50 mg, 1 tablet QD plus FTC/TDF 200/300 mg, 1 coformulated tablet QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject should be antiretroviral naïve (defined as <=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection).
- Age ≥ 18 years
- Screening plasma HIV-1 RNA ≥1000 c/mL
- CD4 cell count nadir: any value
- Effective contraception for women of childbearing potential.
Key exclusion criteria (14 listed)
- History of suicide ideation, intention or action.
- Evidence of HBV infection based on the results of testing at Screening* for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (antiHBs or HBsAb), and HBV DNA as follows: Subjects positive for HBsAg are excluded; Subjects negative for anti-HBs and HBsAg but positive for anti-HBc and positive for HBV DNA are excluded.
- Anticipated need for any HCV therapy during the first 48 weeks of the study.
- Acute symptomatic HIV Infection.
- Any active Opportunistic Infection (category C, CDC 2014).
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 |
|---|---|---|
| Lamivudine 300 MGAlso: 3TC, dolutegravirExperimental arm | Drug | Dolutegravir + lamivudine |
| Emtricitabine / Tenofovir Disoproxil PillAlso: truvada, dolutegravirActive Comparator | Drug | Dolutegravir + emtricitabine/tenofovir (FTC/TDF) |
Primary outcome
Virologic Efficacy
Time frame: 48 weeks
To demonstrate the non-inferior antiviral activity (VL < 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV-1 naïve adult patients without baseline genotypic resistance testing available. Endpoint: Proportion of subjects with plasma HIV-1 RNA <50 copies/mL (c/mL) at Week 48 using the FDA Snapshot algorithm [Missing, Switch or Discontinuation = Failure (MSD=F)] for the intent-to-treat exposed (ITT-E) population.
2 secondary outcomes
Genetic barrier
Time frame: 48 weeks
Efficacy in presence of any major resistanceassociated mutation al baseline
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 21 Feb 2024.
- Derived from this study: PubMed 39826566Cordova E, Hernandez Rendon J, Mingrone V, Martin P, Arevalo Calderon G, Seleme S, Ballivian J, Porteiro N. Efficacy of dolutegravir plus lamivudine in treatment-naive people living with HIV without baseline drug-resistance testing available (D2ARLING): 48-week results of a phase 4, randomised, open-label, non-inferiority trial. Lancet HIV. 2025 Feb;12(2):e95-e104. doi: 10.1016/S2352-3018(24)00294-7. Epub 2025 Jan 15.
- Fundacion IDEAA web pageLink provided by the sponsor.
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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.
Ezequiel Cordova, MD principal investigator
Fundacion IDEAA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamivudine 300 MG and Emtricitabine / Tenofovir Disoproxil Pill in people with Hiv and HIV-1-infection, run by Fundacion IDEAA at 1 site in Argentina.
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 14 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Virologic Efficacy (time frame: 48 weeks). 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 NCT04549467, 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 21 Feb 2024.