HIV-1-infectionPhase 3EDOLASNCT04979468
Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)
A Phase 3 study testing DOVATO in people with HIV-1-infection, run by Societa' Italiana Di Malattie Infettive E Tropicali at 25 sites in Italy.
Trial summary
Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- DOVATO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 25 sitesItaly
- Study dates
- 23 Mar 2021to 1 Apr 2024
- Phase
- Phase 3
- 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 documented infection;
- Aged 18 years or older at the time of signing the informed consent;
- Stable INSTI-based first-line three-drug ART (switch between different NRTIs are allowed; e.g. from TDF/FTC to TAF/FTC or ABC/3TC, from TAF/FTC to TDF/FTC or ABC/3TC, from ABC/3TC to TAF/FTC or TDF/FTC). Any change of INSTI will not be allowed. Only the following regimens will be allowed:
- RAL 1200 mg QD plus TDF/FTC or TAF/FTC;
- RAL 1200 mg QD plus ABC/3TC;
- EVG/COBI/FTC/TDF or EVG/COBI/FTC/TAF;
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- DTG plus TDF/FTC or TAF/FTC;
- DTG/ABC/3TC or DTG plus ABC/3TC;
- BIC/TAF/FTC
- Previous INSTI-based first-line ART lasting less than 18 months before screening;
- To have reached a HIV-1 RNA <50 copies/mL during INSTI first-line therapy for less than 12 months. At least a single HIV-1 RNA determination below the threshold within the 6 months before enrollment is required (if a following determination in present, this should not be ≥50 copies (cp)/mL)
- HIV-1 RNA below 50 copies/mL at the screening visit;
- No known allergy or intolerance to the study drugs or their components or drugs of their class;
- A female person is eligible to enter the study if it is confirmed that she is:
- Not pregnant confirmed by a negative serum pregnancy test at both Screening and Day1;
- Not breastfeeding;
- Of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy;
- Of childbearing potential and agrees to utilize the protocol specified method of contraception (as defined in Appendix 1 -Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential) or be non-heterosexually active or practice sexual abstinence (defined as complete abstinence from penile-vaginal intercourse; periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) from screening throughout the duration of study treatment and for at least two weeks following discontinuation of study drugs;
- Being able to comply with the protocol requirements and restrictions;
- Signature of written Informed Consent Form (participants or legal guardian) before that any protocol-specified assessments are conducted.
Who cannot join
- A person will be considered not eligible for inclusion in this study if any of the following criteria apply:
- Having failed virologically;
- Having changed the INSTI drug;
- Any major INSTI- or NRTI-resistance-associated mutation documented before starting ART;
- Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study;
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-Hbc), hepatitis B surface antigen antibody (anti-HBs) and, possibly, HBV DNA as follows:
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- Individuals positive for HBsAg are excluded;
- Individuals negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded;
- HCV-RNA positivity needing for any hepatitis C virus (HCV) therapy during the study;
- Ongoing malignancy other than cutaneous Kaposi's sarcoma (not requiring systemic therapy), basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia;
- Active opportunistic infections requiring active treatment;
- Creatinine clearance of <50 mL/min/1.73m2 via CKD-EPI method;
- Individuals with severe hepatic impairment (Child Pugh class C) and/or unstable liver disease;
- Any verified Grade 4 laboratory abnormality at screening assessment;
- Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) or ALT >3xULN and bilirubin >1.5xULN (with >35% direct bilirubin) at screening assessment;
- Receipt of investigational research agents within 30 days prior to study entry;
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening;
- Receipt of immunosuppressive medications or immune-modulators within the past 6 months;
- Individuals who in the investigator's judgment, poses a significant suicidality risk or with diagnosed major depression, Bipolar Disorders and Psychoses
- A life expectancy estimated as less than 2 years.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites, 15 recruiting
- Active, not recruiting
Azienda Ospedaliera Universitaria Policlinico di Bari
Bari, BA, 70124
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo, BG, 24127
Franco Maggiolo, P.I., 3388172182, fmaggiolo@asst-pg23.it
Claudia Suardi, D.M., 0352673608, csuardi@fondazionefrom.it
- Active, not recruiting
ARNAS Garibaldi
Catania, CT, 95123
- Not yet recruiting
Azienda Ospedaliera Universitaria Ferrara
Ferrara, FE, 44124
Laura Sighinolfi, P.I., 3479146298, l.sighinolfi@ospfe.it
- Active, not recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, FI, 50134
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, FI, 50134
Massimo Antonio Di Pietro, P.I., 057335111, massimoantonio.dipietro@uslcentro.toscana.it
- Not yet recruiting
Ospedale Policlinico San Martino di Genova
Genova, GE, 16132
Antonio Di Biagio, P.I., 3356269149, adibiagioa@gmail.com
- Active, not recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20127
Antonella Castagna, P.I., 3466732894, castagna.antonella@hsr.it
Elisabetta Carini, D.M., 0226437934, carini.elisabetta@hsr.it
- Not yet recruiting
ASST Fatebenefratelli Sacco
Milan, MI, 20131
20131 Rizzardini, P.I., 0239043490, giuliano.rizzardini@asst-fbf-sacco.it
- Not yet recruiting
ASST Fatebenefratelli Sacco
Milan, MI, 20131
Stefano Rusconi, P.I., 0250319761, stefano.rusconi@unimi.it
- Not yet recruiting
ASST Santi Paolo e Carlo - Presidio San Paolo
Milan, MI, 20142
Antonella d'Arminio Monforte, P.I., 0281843046, antonella.darminio@unimi.it
Valentina Minieri, D.M., 0281844621, valentina.minieri@gmail.com
- Active, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
- Not yet recruiting
Azienda Ospedaliera Universitaria di Modena
Modena, MO, 41124
Cristina Mussini, P.I., 059422246, cristina.mussini@unimore.it
- Not yet recruiting
Ospedale San Gerardo di Monza
Monza, MI, 20900
Giuseppe Lapadula, P.I., 3396640107, g.lapadula@asst.monza.it
- Not yet recruiting
Azienda Ospedaliera di Padova
Padova, PD, 35128
Annamaria Cattelan, P.I., 3337138916, annamaria.cattelan@aopd.veneto.it
Maddalena Cipullo, D.M., maddalena.cipullo@aopd.veneto.it
- Active, not recruiting
A.O.U. Policlinico "Paolo Giaccone"
Palermo, PA, 90127
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Roberto Gulminetti, P.I., 3386784776, r.gulminetti@smatteo.pv.it
- Active, not recruiting
Policlinico Universitario Tor Vergata
Roma, RM, 00133
- Recruiting
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, RM, 00149
Andrea Antinori, P.I., 0655170546, andrea.antinori@inmi.it
Maddalena Plazzi, D.M., 3384093449, maria.plazzi@inmi.it
- Not yet recruiting
A.O.U. Policlinico Umberto I
Roma, RM, 00155
Gabriella d'Ettorre, P.I., 3479650959, gabriella.dettorre@uniroma1.it
- Active, not recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
- Active, not recruiting
Strutture Ospedaliere - Cliniche San Pietro - AOU Sassari
Sassari, SS, 07100
- Active, not recruiting
Azienda Ospedaliera Universitaria Senese
Siena, SI, 53100
- Not yet recruiting
Ospedale Amedeo di Savoia
Torino, TO, 10149
Stefano Bonora, P.I., 0114393860, stefano.bonora@unito.it
About this study
Official title: Efficacy and Safety of Early Switching to Dolutegravir/Lamivudine (DTG/3TC) From INSTI-based Three-drug Regimens in HIV-1-infected Adults Previously naïve Who Achieve Virological Suppression
Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL
Read the detailed description
The target population of this study is HIV-1-infected adults without previous virological failure, currently receiving any first-line, triple-drug ART having an INSTI (EVG/cobi, RAL QD, DTG, BIC) as anchor drug associated to any of the following dual NRTI backbone (ABC/3TC, TDF/FTC or TAF/FTC) with virological suppression (HIV-1 RNA < 50 copies/mL).
Participants will be randomly allocated 1:1 to switch to DTG/3TC 50/300 mg as a single pill qd until week 96 (Arm A, early switch) or to continue their INSTI-based ART triple regimen received at screening (Arm B, delayed switch) until week 52, when participants in Arm B with HIV-1 RNA< 50 cp/mL at week 48 will switch to DTG/3TC 50/300 mg qd as a single pill until week 100.
The drugs of both arms will be administered in an open-label manner throughout the entire duration of the study.
The primary analysis will take place after the last participant completes 52 weeks on therapy, to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 cp/mL at the Week 48 visit.
If the second determination of HIV-1 RNA is <50 cp/mL, then the participant has not a virological rebound and will be considered eligible to switch to DTG/3TC at Week 52.
If the second determination of HIV-1 RNA is ≥50 cp/mL, then the participant will be considered protocol-defined virological failure, thus being ineligible to switch to DTG/ 3TC. These participants will be withdrawn from the study.
A preliminary interim analysis will be performed after 50% of the enrolled participants have reached the 24th week of study, always considering 4 weeks more (thus 28 weeks) to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 copies/mL at Week 24.
At week 48, participants in Arm A (early switch) will continue DTG/3TC. At week 52, participants in Arm B (delayed switch) and with HIV-1 RNA < 50 copies/mL at week 48 will switch to DTG/3TC and will be followed until week 100.
The exploratory analyses at Week 96 will take place after the last participant completes 100 weeks on therapy, as needed, to allow for the collection of a confirmatory viral load measurement in participants presenting with HIV-1 RNA ≥50 copies/mL at Week 96.
- Conditions
- HIV-1-infection
- Being tested
- DOVATO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOVATODrug
Also called dolutegravir/lamivudine
Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Other | Participants in Arm A will be randomized to switch to DTG/3TC 50/300 mg QD until week 48 (early switch). Receives: Drug: DOVATO |
| ARM B | Other | Participants in Arm B will continue the INSTI-based ART regimen until week 48, and then will be switched to DTG/3TC through week 96 (delayed switch). Receives: Drug: DOVATO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferior efficacy of switching
Proportion of participants with virological rebound (viral load ≥50 copies/mL or premature discontinuations, irrespective of reason, with last viral load ≥50 copies/mL) at week 48
Measured: 48 weeks
Secondary outcomes (8)
Efficacy of switching
Proportion of participants with HIV-1 RNA <50 copies/mL at week 48 (FDA Snapshot algorithm)
Measured: 48 weeks
Safety and tolerability
Clinical and laboratory safety parameters; a descriptive analysis of all reported AEs and a quantitative analysis of AEs leading to treatment interruption/change will be used to evaluate long-term tolerability of the simplification treatment.
Measured: 100 weeks
Immunologic response and dysfunction
Changes in CD4+ and CD8+ T-lymphocyte counts (absolute and percentage), and in CD4+/CD8+ ratio (as a measure of immune activation) in the peripheral blood from baseline to week 48 and 96.
Measured: 100 weeks
Emergent drug resistance-associated mutations
Proportion of participants developing resistance-conferring mutations (to any drug class) by genotypic resistance test (GRT) in plasma or proviral DNA (in case of low viremia levels, <200 copies/mL) at protocol-defined virological failure (PDVF) will be cumulatively described throughout the study period.
Measured: 100 weeks
RT and INSTI resistance-associated mutations
iral minority variants harboring resistance associated mutations (to any drug class) at the time of PDVF will be characterized in plasma or in proviral DNA (in case of low viremia levels, <200 copies/mL) by next generation sequencing. For the minority resistant variants detected (prevalence >1%), their resistance viral burden will be also evaluated.
Measured: 100 weeks
Effects of the two strategies on Lipidic profile
Changes in fasting lipids (TC, LDL, HDL, non-HDL, TC/HDL) from baseline to w48 and 96.
Measured: 96 weeks
Adherence levels to ARVs
Changes of self-reported adherence level and proportion of participants with different adherence level (95%; 90%; 80%) from baseline to week 48 and 96.
Measured: 96 weeks
Evaluate neuropsychiatric symptoms.
Change in neuropsychiatric questionnaire scores, assessing mood, anxiety, sleep quality, and suicidality from baseline to week 24, 48 and 96.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start23 Mar 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA \<50 copies/mL
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa' Italiana Di Malattie Infettive E Tropicali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Andreoni, P.I., Principal investigator, Policlinico Universitario Tor VergataAlessandra Bandera, P.I., Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoAlessandro Bartoloni, P.I., Principal investigator, Azienda Ospedaliero-Universitaria CareggiStefano Bonora, P.I., Principal investigator, Ospedale Amedeo di SavoiaAntonio Cascio, P.I., Principal investigator, A.O.U. Policlinico "Paolo Giaccone"Antonella Castagna, P.I., Principal investigator, IRCCS Ospedale San RaffaeleAnnamaria Cattelan, P.I., Principal investigator, Azienda Ospedaliera di PadovaRoberto Cauda, P.I., Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979468
- Sponsor's protocol ID
- 2019-004241-32
- Other IDs
- 2019
- Acronym
- EDOLAS
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early Switching to Dolutegravir/Lamivudine (DTG/3TC) From INSTI-based Three-drug Regimens in HIV-1-infected Adults Previously naïve Who Achieve Virological Suppression
- ClinicalTrials.gov ID
- NCT04979468
- Acronym / sponsor ID
- EDOLAS / 2019-004241-32
- Conditions
- HIV-1-infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Societa' Italiana Di Malattie Infettive E TropicaliUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 28 Jul 2021 (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.
Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL
Detailed description
The target population of this study is HIV-1-infected adults without previous virological failure, currently receiving any first-line, triple-drug ART having an INSTI (EVG/cobi, RAL QD, DTG, BIC) as anchor drug associated to any of the following dual NRTI backbone (ABC/3TC, TDF/FTC or TAF/FTC) with virological suppression (HIV-1 RNA < 50 copies/mL).
Participants will be randomly allocated 1:1 to switch to DTG/3TC 50/300 mg as a single pill qd until week 96 (Arm A, early switch) or to continue their INSTI-based ART triple regimen received at screening (Arm B, delayed switch) until week 52, when participants in Arm B with HIV-1 RNA< 50 cp/mL at week 48 will switch to DTG/3TC 50/300 mg qd as a single pill until week 100.
The drugs of both arms will be administered in an open-label manner throughout the entire duration of the study.
The primary analysis will take place after the last participant completes 52 weeks on therapy, to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 cp/mL at the Week 48 visit.
If the second determination of HIV-1 RNA is <50 cp/mL, then the participant has not a virological rebound and will be considered eligible to switch to DTG/3TC at Week 52.
If the second determination of HIV-1 RNA is ≥50 cp/mL, then the participant will be considered protocol-defined virological failure, thus being ineligible to switch to DTG/ 3TC. These participants will be withdrawn from the study.
A preliminary interim analysis will be performed after 50% of the enrolled participants have reached the 24th week of study, always considering 4 weeks more (thus 28 weeks) to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 copies/mL at Week 24.
At week 48, participants in Arm A (early switch) will continue DTG/3TC. At week 52, participants in Arm B (delayed switch) and with HIV-1 RNA < 50 copies/mL at week 48 will switch to DTG/3TC and will be followed until week 100.
The exploratory analyses at Week 96 will take place after the last participant completes 100 weeks on therapy, as needed, to allow for the collection of a confirmatory viral load measurement in participants presenting with HIV-1 RNA ≥50 copies/mL at Week 96.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL
| Arm | Type | Receives |
|---|---|---|
| ARM A | Other | Drug: DOVATOParticipants in Arm A will be randomized to switch to DTG/3TC 50/300 mg QD until week 48 (early switch). |
| ARM B | Other | Drug: DOVATOParticipants in Arm B will continue the INSTI-based ART regimen until week 48, and then will be switched to DTG/3TC through week 96 (delayed switch). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- HIV-1 documented infection;
- Aged 18 years or older at the time of signing the informed consent;
- Stable INSTI-based first-line three-drug ART (switch between different NRTIs are allowed; e.g. from TDF/FTC to TAF/FTC or ABC/3TC, from TAF/FTC to TDF/FTC or ABC/3TC, from ABC/3TC to TAF/FTC or TDF/FTC). Any change of INSTI will not be allowed. Only the following regimens will be allowed:
- Previous INSTI-based first-line ART lasting less than 18 months before screening;
- To have reached a HIV-1 RNA <50 copies/mL during INSTI first-line therapy for less than 12 months. At least a single HIV-1 RNA determination below the threshold within the 6 months before enrollment is required (if a following determination in present, this should not be ≥50 copies (cp)/mL)
Key exclusion criteria (20 listed)
- A person will be considered not eligible for inclusion in this study if any of the following criteria apply:
- Having failed virologically;
- Having changed the INSTI drug;
- Any major INSTI- or NRTI-resistance-associated mutation documented before starting ART;
- Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study;
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 |
|---|---|---|
| DOVATOAlso: dolutegravir/lamivudineDovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). | Drug | ARM A, ARM B |
Primary outcome
Non-inferior efficacy of switching
Time frame: 48 weeks
Proportion of participants with virological rebound (viral load ≥50 copies/mL or premature discontinuations, irrespective of reason, with last viral load ≥50 copies/mL) at week 48
8 secondary outcomes
Efficacy of switching
Time frame: 48 weeks
Safety and tolerability
Time frame: 100 weeks
Immunologic response and dysfunction
Time frame: 100 weeks
Emergent drug resistance-associated mutations
Time frame: 100 weeks
RT and INSTI resistance-associated mutations
Time frame: 100 weeks
Effects of the two strategies on Lipidic profile
Time frame: 96 weeks
Adherence levels to ARVs
Time frame: 96 weeks
Evaluate neuropsychiatric symptoms.
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- eCRF Home pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Andreoni, P.I. principal investigator
Policlinico Universitario Tor Vergata
Alessandra Bandera, P.I. principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Alessandro Bartoloni, P.I. principal investigator
Azienda Ospedaliero-Universitaria Careggi
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DOVATO in people with HIV-1-infection, run by Societa' Italiana Di Malattie Infettive E Tropicali at 25 sites in Italy.
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 20 inclusion and 20 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Antinori, P.I. (0655170546, andrea.antinori@inmi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferior efficacy of switching (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.