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| Name | Class |
|---|---|
| Maasstad Hospital | OTHER |
| Haaglanden Medical Centre | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Elisabeth-TweeSteden Ziekenhuis |
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This study aims to determine real-life clinical efficacy of virally suppressed patienst switching to DTG/3TC compared to DTG triple drug cART controls
Dolutegravir (DTG) based dual antiretroviral therapy constitutes a paradigm shift from triple drug based therapy. Data outside clinical trials are scarce. This study evaluates the value of DTG/3TC in real life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTG based switchers to DTG/3TC | HIVRNA suppressed HIV patients who switched to DTG/3TC | ||
| DTG based triple drug cART | Matched HIVRNA suppressed patients who remained on triple drug DTG based cART | ||
| non-DTG based switchers to DTG/3TC |
| ||
| non-DTG based triple drug cART | Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir / Lamivudine Pill | Drug | HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy On Treatment (OT) | Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the on treatment population | 1 year |
| Efficacy Intention to Treat (ITT) | Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the intention to treat population. | 1 year |
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Inclusion Criteria:
Plasma HIVRNA <50c/mL on triple drug cART regimen including 2NRTI In care in a HIV treatment center in the Netherlands Consented to ATHENA participation
Exclusion Criteria:
Documented mutations associated with 3TC or DTG resistance of at least low level Documented inadherence by the treating physician or HepB coinfection (cases only)
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To be eligible as case in the study, plasma HIVRNA must be <50c/mL on triple drug cART containing 2NRTI at switch to DTG/3TC and no key mutations associated with major 3TC (i.e. M184V/I only) or DTG resistance of at least low level according to the Stanford HIV drug resistance database should be present. Patients with no genotyping results available at baseline will be eligible for inclusion in this study. Cases should not have documented inadherence in the preceding 3 months or HepB coinfections. These data on adherence and HepB is routinely collected at switching to DTG/3TC. Controls are matched on predefined criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Netherlands | ||||
| Catharina Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38567196 | Derived | Vasylyev M, Wit FWNM, Jordans CCE, Soetekouw R, van Lelyveld SFL, Kootstra GJ, Delsing CE, Ammerlaan HSM, van Kasteren MEE, Brouwer AE, Leyten EMS, Claassen MAA, Hassing RJ, den Hollander JG, van den Berge M, Roukens AHE, Bierman WFW, Groeneveld PHP, Lowe SH, van Welzen BJ, Richel O, Nellen JF, van den Berk GEL, van der Valk M, Rijnders BJA, Rokx C. Dolutegravir/Lamivudine Is Noninferior to Continuing Dolutegravir- and Non-Dolutegravir-Based Triple-Drug Antiretroviral Therapy in Virologically Suppressed People With Human Immunodeficiency Virus: DUALING Prospective Nationwide Matched Cohort Study. Open Forum Infect Dis. 2024 Mar 18;11(4):ofae160. doi: 10.1093/ofid/ofae160. eCollection 2024 Apr. |
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Other research groups can contact the PI with a research question to obtain IPD.
Up to 15 years
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| ID | Title | Description |
|---|---|---|
| FG000 | DTG Based Switchers to DTG/3TC | HIVRNA suppressed HIV patients who switched to DTG/3TC |
| FG001 | DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug DTG based cART |
| FG002 | Non-DTG Based Switchers to DTG/3TC | Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B |
| FG003 | Non-DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DTG Based Switchers to DTG/3TC | HIVRNA suppressed HIV patients who switched to DTG/3TC |
| BG001 | DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug DTG based cART |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy On Treatment (OT) | Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the on treatment population | Posted | Count of Participants | Participants | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DTG Based Switchers to DTG/3TC | HIVRNA suppressed HIV patients who switched to DTG/3TC |
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All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were collected during this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Casper Rokx | ErasmusMC | +310107040704 | c.rokx@erasmusmc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2020 | Jul 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| OTHER |
| Rijnstate Hospital | OTHER |
| Admiraal de Ruyter Hospital | OTHER |
| Spaarne Gasthuis | OTHER |
| Medisch Spectrum Twente | OTHER |
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| Eindhoven |
| Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| Admiraal de Ruyter Ziekenhuis | Goes | Netherlands |
| Spaarne Gasthuis | Haarlem | Netherlands |
| Erasmus MC | Rotterdam | 3015 CN | Netherlands |
| MC Haaglanden | Rotterdam | 3015 CN | Netherlands |
| Maasstad Hospital | Rotterdam | Netherlands |
| Elisabeth Tweesteden Hospital | Tilburg | Netherlands |
| BG002 | Non-DTG Based Switchers to DTG/3TC | Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B |
| BG003 | Non-DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| CD4 count nadir | Median | Inter-Quartile Range | cells/mcL |
|
Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B |
| OG003 | Non-DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART |
|
|
| Primary | Efficacy Intention to Treat (ITT) | Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the intention to treat population. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 390 |
| 0 |
| 390 |
| 0 |
| 390 |
| EG001 | DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug DTG based cART | 0 | 780 | 0 | 780 | 0 | 780 |
| EG002 | Non-DTG Based Switchers to DTG/3TC | Dolutegravir / Lamivudine Pill: HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B | 0 | 290 | 0 | 290 | 0 | 290 |
| EG003 | Non-DTG Based Triple Drug cART | Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART | 0 | 580 | 0 | 580 | 0 | 580 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |