HIV InfectionsPhase 4D²EFTNCT03017872
Dolutegravir and Darunavir Evaluation in Adults Failing Therapy
A Phase 4 study testing NRTIs, Dolutegravir and Darunavir in people with HIV Infections, run by Kirby Institute at 28 sites in 14 countries.
Trial summary
D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- NRTIs, Dolutegravir and Darunavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 831 participants
- Where
- 28 sitesin 14 countries
- Study dates
- 23 Nov 2017to 31 Oct 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
- HIV-1 positive by licensed diagnostic test
- Aged ≥16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
- Failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) + 2N(t)RTI combination therapy according to virological criteria, defined as at least two consecutive (≥7 days apart) pVL results >500 copies/mL after a minimum period of exposure to continuous NNRTI + 2N(t)RTI first-line therapy of 24 weeks (only the second pVL result needs to be within 45 days of randomisation)
- For women of child-bearing potential, willingness to use appropriate contraception
- Able to provide written informed consent
Who cannot join
- The following laboratory variables:
- absolute neutrophil count (ANC) <500 cells/µL
- haemoglobin <7.0 g/dL
- platelet count <50,000 cells/µL
- AST and/or ALT ≥5xULN OR ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin)
- Change in antiretroviral therapy within 12 weeks prior to randomisation
Show all 18Show fewer
- Prior exposure to HIV protease inhibitors and/or HIV integrase inhibitors
- Patients with chronic viral hepatitis B infection defined by positive serum hepatitis B surface antigen
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy (INR >2.3), hypoalbuminemia (serum albumin <2.8g/dL), esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Anticipated need for Hepatitis C virus (HCV) therapy during the study
- Subject has creatinine clearance of <50 mL/min via CKD-EPI equation
- Current use of rifabutin or rifampicin
- Use of any contraindicated medications (as specified by product information sheets)
- Intercurrent illness requiring hospitalization
- An active opportunistic disease not under adequate control in the opinion of the investigator
- Pregnant or nursing mothers
- Patients with current alcohol or illicit substance use that in the opinion of the investigator might adversely affect participation in the study
- Patients deemed unlikely by the investigator to be able to remain in follow-up for the protocol-defined period
Trial locations and contacts
28 sites in 14 countries.
28 sites in 14 countries
Argentina4 sites
Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Buenos Aires F.D., C1221ADC
Hospital Dr Diego Paroissien
Isidro Casanova, Buenos Aires, 1765
Hospital Interzonal de Agudos San Juan de Dios
La Plata, 1900
CAICI
Rosario, Santa Fe Province, S2000PBJ
Indonesia4 sites
Dr. Cipto Mangunkusumo Hospital
Jakarta, 10320
RSUP Dr. Wahidin Sudirohusodo
Makassar, 90241
Dr. Soetomo Hospital
Surabaya, 60285
Dr Sardjito Hospital
Yogyakarta, 55284
Thailand4 sites
HIV-NAT (The HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Centre
Bangkok, 10330
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, 11000
Mexico3 sites
Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44280
Morales Vargas Centro de Investigacion SC
León, Guanajuato, 37000
Instituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran
Mexico City, 14080
South Africa3 sites
Desmond Tutu HIV Foundation
Cape Town, 7925
Clinical HIV Research Unit (CHRU), Wits Health Consotium (Pty) Ltd
Johannesburg, 2041
Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital
Soweto, 1864
Malaysia2 sites
Hospital Pulau Pinang
George Town, Pulau Pinang, 10450
University of Malaya Medical Centre
Kuala Lumpur, 59100
Brazil1 site
Laboratório de Pesquisa Clinica Em Hiv/Aids - Instituto Nacional de Infectologia - Fiocruz
Rio de Janeiro, 21040-360
Colombia1 site
ASISTENCIA Cientifica De Alta Complejidad S.A.S.
Bogotá, 110010
Guinea1 site
Centre de traitementambulatoire de Donka ( Hopital de jour)
Conakry, BP:5845
Mali1 site
University of Sciences, Techniques and Technologies of Mali, University Clinical Research Center (UCRC)
Bamako
About this study
Official title: A Phase IIIB/IV Randomised Open-label Trial Comparing Dolutegravir With Pharmaco-enhanced Darunavir Versus Dolutegravir With Predetermined Nucleosides Versus Recommended Standard of Care ART Regimens in Patients With HIV-1 Infection Failing First Line Therapy.
D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.
Read the detailed description
Consenting participants will be screened and within 45 days randomly allocated to receive either dolutegravir and darunavir/ritonavir, dolutegravir and 2 prespecified NRTIs or the SOC regimen. Participants will be seen four weeks after their randomisation (week 0) visit and then at weeks 12, 24, 48 and 96. Consenting participants will have storage samples collected and cryopreserved at their week 0, 48 \& 96 visits. This repository will be used in future for central baseline resistance testing, pharmacogenomic testing (separate consent required) and has inherent value for later studies of HIV pathogenesis. A 1-time PK sample will be collected at week four for future testing and any participants failing therapy at 24 weeks will have a plasma sample stored for future genotypic resistance testing.
A number of secondary outcomes will be considered in order to compare the performance of the two study treatment regimens. Secondary analyses will focus on virological, immunological, safety, antiretroviral treatment change and medication adherence. A comparison of costs and estimates of cost-effectiveness for the randomised comparison will be a critical component of this study. ART costs will be assessed across study arms. Health-care utilisation will be self-reported and then used to estimate costs. Safety data, viral loads and quality of life data will also be analysed.
The open label nature of the study allows routine care to be undertaken and the use of objective endpoints limit potential bias. The study has well defined and integrated clinical data collection and patient management systems that have been shown to be effective in a wide range of clinical settings.
The choice of NRTIs in the SoC regimen is based on clinical judgement and may be guided by resistance testing if locally available, while those used with dolutegravir are predetermined (tenofovir and lamivudine or emtricitabine). The NRTIs are not provided via the study. At the end of 96 weeks (completion of the protocol) study drug can be offered to all participants for a further 48 weeks as informed by the 48-week study results and clinical judgement. After 144 weeks study drug will no longer be available and composition of the participant's post-study regimen will be the clinician's decision.'
- Conditions
- HIV Infections
- Being tested
- NRTIs, Dolutegravir, Darunavir, Ritonavir
- Keywords
- HIV, second-line
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRTIsDrug
Also called Nucleoside/Nucleotide Reverse Transcription Inhibitors
In SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection.
In D2N arm, NRTIs are predetermined.
DolutegravirDrug
Also called Tivicay
50mg tablet by mouth once daily for 96 weeks.
DarunavirDrug
Also called Prezista
800mg tablet by mouth once daily for 96 weeks.
RitonavirDrug
Also called Norvir
100mg tablet by mouth once daily for 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) arm | Active comparator | 2 x NRTIs + darunavir/ritonavir 800mg/100mg po od Receives: Drug: NRTIs; Drug: Darunavir; Drug: Ritonavir |
| Dolutegravir arm | Experimental | Dolutegravir 50mg + darunavir/ritonavir 800mg/100mg po od Receives: Drug: Dolutegravir; Drug: Darunavir; Drug: Ritonavir |
| Dolutegravir 2NRTI arm (D2N) | Experimental | Dolutegravir 50mg + 2 x NRTIs (tenofovir plus emtricitabine or lamivudine) Receives: Drug: NRTIs; Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants in each arm whose plasma viral load is <50 copies/mL at 48 weeks by intention to treat.
Measured: At 48 weeks
Secondary outcomes (14)
Proportion with plasma viral load <200 copies/mL
Measured: At 48 and 96 weeks
Proportion with plasma viral load <50 copies/mL where those stopping randomised therapy for any reason are classified as plasma viral load >50 copies/mL
Measured: At 48 and 96 weeks
Mean change in CD4+ cell count from baseline
Measured: At 48 and 96 weeks
Mean/median changes from baseline in fasted lipids (Total cholesterol, LDL-c, HDL-c, and triglycerides)
Measured: At 48 and 96 weeks
Total number of participants with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Measured: At 48 and 96 weeks
Total number of opportunistic diseases (AIDS events), deaths and serious non-AIDS defining events and the cumulative incidence of these
Measured: At 48 and 96 weeks
Adverse events associated with cessation of randomly assigned therapy
Measured: At 48 and 96 weeks
Categorisation of neuropsychological adverse events
Measured: At 48 and 96 weeks
Proportion who stopped randomised therapy by reason for stopping
Measured: At 48 and 96 weeks
Patterns of genotypic HIV resistance associated with virological failure
Measured: At 48 and 96 weeks
Adherence assessment using participant 7-day recall self-report questionnaire
Measured: At week 4
Quality of life and anxiety & depression assessed by participant questionnaire
Measured: At 48 and 96 weeks
Health care utilisation assessed by participant questionnaire
Measured: At 48 and 96 weeks
Cost of care assessment
Measured: At 48 and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start23 Nov 2017
- Primary completion11 Nov 2022
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Model description
- A third arm has been incorporated using a multi-arm, multi-stage (MAMS) design. This design allows for the 2-arm study (DTG+DRV/r vs DRV/r+2NRTI) to continue accrual while preparation of the new arm (DTG+2NRTI) is begun in parallel. Once that arm is ready, accrual to it begins and the study switches to the second stage. All participants accrued to Arm 1 and 2 throughout the trial are contemporaneous and can be compared, while the subjects accrued to Arm 3 are compared only to their contemporaries in Arms 1 and 2. The size of Arm 3 is sufficient to allow adequate power comparisons, and stage effects are minimized while non-contemporaneous control data are not required.
- Masking
- None (open label)
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- UNITAID, National Institute of Allergy and Infectious Diseases (NIAID), National Health and Medical Research Council, Australia, ViiV Healthcare, Janssen Pharmaceutica
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017872
- Sponsor's protocol ID
- D2EFT
- Other IDs
- 18Q065, 19Q120
- Acronym
- D²EFT
- Status last verified
- Sep 2022
- First submitted
- 2 Jan 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nyein PP, Donoghoe MW, Eriobu N, Uche B, Kaplan R, Carey D, Brown D, Kundro M, Dharan NJ, Hanson J, Petoumenos K, Matthews GV; the D EFT study group. Cardiometabolic impact of dolutegravir as second-line therapy: secondary analysis of a randomized controlled trial. AIDS. 2026 Jul 1;40(7):937-948. doi: 10.1097/QAD.0000000000004476. Epub 2026 Mar 2.
PubMed 41779383D2EFT Study Group. Dolutegravir plus boosted darunavir versus recommended standard-of-care antiretroviral regimens in people with HIV-1 for whom recommended first-line non-nucleoside reverse transcriptase inhibitor therapy has failed (D2EFT): an open-label, randomised, phase 3b/4 trial. Lancet HIV. 2024 Jul;11(7):e436-e448. doi: 10.1016/S2352-3018(24)00089-4. Epub 2024 May 21.
PubMed 38788744Nyein PP, Petoumenos K, Borok M, Eriobu N, Kumarasamy N, Avihingsanon A, Azwa I, Dao S, Cisse M, Dharan NJ, Hanson J, Matthews GV. Associations Between Antiretroviral Regimen and Changes in Blood Pressure: Results From the D2EFT Study. Clin Infect Dis. 2025 Feb 5;80(1):160-163. doi: 10.1093/cid/ciae256.
PubMed 38721980
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB/IV Randomised Open-label Trial Comparing Dolutegravir With Pharmaco-enhanced Darunavir Versus Dolutegravir With Predetermined Nucleosides Versus Recommended Standard of Care ART Regimens in Patients With HIV-1 Infection Failing First Line Therapy.
- ClinicalTrials.gov ID
- NCT03017872
- Acronym / sponsor ID
- D²EFT / D2EFT
- Conditions
- HIV Infections
- Keywords
- HIV, second-line
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- UNITAID, National Institute of Allergy and Infectious Diseases (NIAID), National Health and Medical Research Council, Australia, ViiV Healthcare, Janssen Pharmaceutica
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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.
D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs) with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that one or both of the new regimens will be non-inferior to SOC in terms of virologic control while being easier to take, economically viable and affording simplification of treatment programs.
Detailed description
Consenting participants will be screened and within 45 days randomly allocated to receive either dolutegravir and darunavir/ritonavir, dolutegravir and 2 prespecified NRTIs or the SOC regimen. Participants will be seen four weeks after their randomisation (week 0) visit and then at weeks 12, 24, 48 and 96. Consenting participants will have storage samples collected and cryopreserved at their week 0, 48 \& 96 visits. This repository will be used in future for central baseline resistance testing, pharmacogenomic testing (separate consent required) and has inherent value for later studies of HIV pathogenesis. A 1-time PK sample will be collected at week four for future testing and any participants failing therapy at 24 weeks will have a plasma sample stored for future genotypic resistance testing.
A number of secondary outcomes will be considered in order to compare the performance of the two study treatment regimens. Secondary analyses will focus on virological, immunological, safety, antiretroviral treatment change and medication adherence. A comparison of costs and estimates of cost-effectiveness for the randomised comparison will be a critical component of this study. ART costs will be assessed across study arms. Health-care utilisation will be self-reported and then used to estimate costs. Safety data, viral loads and quality of life data will also be analysed.
The open label nature of the study allows routine care to be undertaken and the use of objective endpoints limit potential bias. The study has well defined and integrated clinical data collection and patient management systems that have been shown to be effective in a wide range of clinical settings.
The choice of NRTIs in the SoC regimen is based on clinical judgement and may be guided by resistance testing if locally available, while those used with dolutegravir are predetermined (tenofovir and lamivudine or emtricitabine). The NRTIs are not provided via the study. At the end of 96 weeks (completion of the protocol) study drug can be offered to all participants for a further 48 weeks as informed by the 48-week study results and clinical judgement. After 144 weeks study drug will no longer be available and composition of the participant's post-study regimen will be the clinician's decision.'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A third arm has been incorporated using a multi-arm, multi-stage (MAMS) design. This design allows for the 2-arm study (DTG+DRV/r vs DRV/r+2NRTI) to continue accrual while preparation of the new arm (DTG+2NRTI) is begun in parallel. Once that arm is ready, accrual to it begins and the study switches to the second stage. All participants accrued to Arm 1 and 2 throughout the trial are contemporaneous and can be compared, while the subjects accrued to Arm 3 are compared only to their contemporaries in Arms 1 and 2. The size of Arm 3 is sufficient to allow adequate power comparisons, and stage effects are minimized while non-contemporaneous control data are not required.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) arm | Active comparator | Drug: NRTIs, Drug: Darunavir, Drug: Ritonavir2 x NRTIs + darunavir/ritonavir 800mg/100mg po od |
| Dolutegravir arm | Experimental | Drug: Dolutegravir, Drug: Darunavir, Drug: RitonavirDolutegravir 50mg + darunavir/ritonavir 800mg/100mg po od |
| Dolutegravir 2NRTI arm (D2N) | Experimental | Drug: NRTIs, Drug: DolutegravirDolutegravir 50mg + 2 x NRTIs (tenofovir plus emtricitabine or lamivudine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 positive by licensed diagnostic test
- Aged ≥16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
- Failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) + 2N(t)RTI combination therapy according to virological criteria, defined as at least two consecutive (≥7 days apart) pVL results >500 copies/mL after a minimum period of exposure to continuous NNRTI + 2N(t)RTI first-line therapy of 24 weeks (only the second pVL result needs to be within 45 days of randomisation)
- For women of child-bearing potential, willingness to use appropriate contraception
- Able to provide written informed consent
Key exclusion criteria (18 listed)
- The following laboratory variables:
- Change in antiretroviral therapy within 12 weeks prior to randomisation
- Prior exposure to HIV protease inhibitors and/or HIV integrase inhibitors
- Patients with chronic viral hepatitis B infection defined by positive serum hepatitis B surface antigen
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy (INR >2.3), hypoalbuminemia (serum albumin <2.8g/dL), esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
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 |
|---|---|---|
| NRTIsAlso: Nucleoside/Nucleotide Reverse Transcription InhibitorsIn SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection. In D2N arm, NRTIs are predetermined. | Drug | Dolutegravir 2NRTI arm (D2N), Standard of Care (SoC) arm |
| DolutegravirAlso: Tivicay50mg tablet by mouth once daily for 96 weeks. | Drug | Dolutegravir 2NRTI arm (D2N), Dolutegravir arm |
| DarunavirAlso: Prezista800mg tablet by mouth once daily for 96 weeks. | Drug | Dolutegravir arm, Standard of Care (SoC) arm |
| RitonavirAlso: Norvir100mg tablet by mouth once daily for 96 weeks. | Drug | Dolutegravir arm, Standard of Care (SoC) arm |
Primary outcome
The proportion of participants in each arm whose plasma viral load is <50 copies/mL at 48 weeks by intention to treat.
Time frame: At 48 weeks
14 secondary outcomes
Proportion with plasma viral load <200 copies/mL
Time frame: At 48 and 96 weeks
Proportion with plasma viral load <50 copies/mL where those stopping randomised therapy for any reason are classified as plasma viral load >50 copies/mL
Time frame: At 48 and 96 weeks
Mean change in CD4+ cell count from baseline
Time frame: At 48 and 96 weeks
Mean/median changes from baseline in fasted lipids (Total cholesterol, LDL-c, HDL-c, and triglycerides)
Time frame: At 48 and 96 weeks
Total number of participants with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Time frame: At 48 and 96 weeks
Total number of opportunistic diseases (AIDS events), deaths and serious non-AIDS defining events and the cumulative incidence of these
Time frame: At 48 and 96 weeks
Adverse events associated with cessation of randomly assigned therapy
Time frame: At 48 and 96 weeks
Categorisation of neuropsychological adverse events
Time frame: At 48 and 96 weeks
Proportion who stopped randomised therapy by reason for stopping
Time frame: At 48 and 96 weeks
Patterns of genotypic HIV resistance associated with virological failure
Time frame: At 48 and 96 weeks
Adherence assessment using participant 7-day recall self-report questionnaire
Time frame: At week 4
Quality of life and anxiety & depression assessed by participant questionnaire
Time frame: At 48 and 96 weeks
Health care utilisation assessed by participant questionnaire
Time frame: At 48 and 96 weeks
Cost of care assessment
Time frame: At 48 and 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 41779383Nyein PP, Donoghoe MW, Eriobu N, Uche B, Kaplan R, Carey D, Brown D, Kundro M, Dharan NJ, Hanson J, Petoumenos K, Matthews GV; the D EFT study group. Cardiometabolic impact of dolutegravir as second-line therapy: secondary analysis of a randomized controlled trial. AIDS. 2026 Jul 1;40(7):937-948. doi: 10.1097/QAD.0000000000004476. Epub 2026 Mar 2.
- Derived from this study: PubMed 38788744D2EFT Study Group. Dolutegravir plus boosted darunavir versus recommended standard-of-care antiretroviral regimens in people with HIV-1 for whom recommended first-line non-nucleoside reverse transcriptase inhibitor therapy has failed (D2EFT): an open-label, randomised, phase 3b/4 trial. Lancet HIV. 2024 Jul;11(7):e436-e448. doi: 10.1016/S2352-3018(24)00089-4. Epub 2024 May 21.
- Derived from this study: PubMed 38721980Nyein PP, Petoumenos K, Borok M, Eriobu N, Kumarasamy N, Avihingsanon A, Azwa I, Dao S, Cisse M, Dharan NJ, Hanson J, Matthews GV. Associations Between Antiretroviral Regimen and Changes in Blood Pressure: Results From the D2EFT Study. Clin Infect Dis. 2025 Feb 5;80(1):160-163. doi: 10.1093/cid/ciae256.
- Individual participant dataSharing planned: No
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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.
Gail Matthews, MD principal investigator
Kirby Institute
28 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NRTIs, Dolutegravir and Darunavir in people with HIV Infections, run by Kirby Institute at 28 sites in 14 countries.
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 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Argentina, Indonesia, Thailand, Mexico, South Africa and 9 more countries. 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?
Results are not available in the source record.
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 in each arm whose plasma viral load is <50 copies/mL at 48 weeks by intention to treat. (time frame: At 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 NCT03017872, which also lists 3 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 18 Apr 2023.