HIV InfectionsPhase 2VOLVERNCT04880785
Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine
A Phase 2 study testing Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato] in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 17 sites in Spain.
Trial summary
Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1. However, data regarding the efficacy of this regimen in suppressed persons with history of past resistance or virologic failures is currently insufficient. 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?
- Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 17 sitesSpain
- Study dates
- 28 Jul 2021to 9 Apr 2024
- Phase
- Phase 2
- 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
- Adults (>=18 years old) with HIV-1 infection able to understand and give informed written consent.
- Stable ART in the 12 weeks prior to screening visit.
- Only switch for tolerability/convenience/access reasons to generic drugs or switch from ritonavir to cobicistat or TDF to TAF would be allowed in the 12-week window and as long as the components of the regimen are unchanged.
- Viral load <50 copies/mL at screening and in the year prior to study entry.
- A blip (50-500 copies/ml) would be allowed within 48 weeks prior to inclusion in the study, if preceded and followed by an undetectable VL determination.
- CD4 count > 200 cel/μL at screening.
Show all 10Show fewer
- History of 3TC resistance: either confirmed historical 3TC resistance (historical RNA Sanger or RNA NGS>20% threshold genotype with M184V/I mutation) OR suspected historical 3TC resistance.
- Suspicion of past 3TC resistance is defined as any of the following:
- Previous treatment with only 2 NRTIs (1 of them being emtricitabine or 3TC [XTC]).
- Two consecutive VL > 200 cp/mL while on treatment including XTC. iii. One VL > 200 cp/mL while on treatment including XTC PLUS change of ART as consequence of that elevated VL.
Who cannot join
- Participants with M184V/I or K65R in screening visit proviral DNA Sanger genotype.
- Prior virologic failure (VF) under integrase inhibitor (INSTI)- based regimen. defined as two consecutive VL > 200 copies/mL while receiving INSTI regardless of genotypic test results
- INSTI resistance mutations in historical RNA genotype.
- Positive Surface Hepatitis B Ag (HBAgS) OR negative HBAgS and negative hepatitis B surface antibody (anti-HBs) with positive anti-core antibody (anti-HBc) and positive HBV DNA.
- Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods (see Appendix 1 for the accepted list of the highly effective methods for avoiding pregnancy), for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
- Patients with active opportunistic infections or cancer requiring intravenous treatment and/or chemotherapy at screening.
Show all 14Show fewer
- Any comorbidities or treatment with experimental drugs that according to the investigator could bias study results or entail additional risks for the participant.
- Participants receiving other medications that according to study drug label are contraindicated.
- Severe hepatic impairment (Class C) as determined by Child-Pugh classification.
- Alanine aminotransferase (ALT) over 5 times the upper limit of normal (ULN) or ALT over 3xULN and bilirubin over 1.5xULN.
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones);
- Creatinine clearance of <30 mL/min/1.73m2 via CKD-EPI method.
- Any verified Grade 4 laboratory abnormality that to the investigators criteria would affect the safety of the participant if included in the study.
- History or presence of allergy to dolutegravir or lamivudine.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
CHUAC
A Coruña, Coruña
H. de Elche
Alicante, Alicante
H. General de Alicante
Alicante, Alicante
H. Bellvitge
Barcelona, Barcelona
H. Clinic
Barcelona, Barcelona
H. del Mar
Barcelona, Barcelona
H. de Donosti
Donostia / San Sebastian, Donostia
H. Fundación Jimenez Díaz
Madrid, Madrid
H. Infanta Leonor
Madrid, Madrid
H. La Princesa
Madrid, Madrid
H. Príncipe de Asturias
Madrid, Madrid
H. Severo Ochoa
Madrid, Madrid
Hospital 12 de Octubre
Madrid, Madrid
Hospital General Univ. Gregorio Marañón
Madrid, Madrid
Hospital Univ. La Paz
Madrid, Madrid
H. Virgen de la Victoria
Málaga, Málaga
H. Álvaro Cunqueiro
Vigo, Pontevedra
About this study
Official title: Virologic Outcomes of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine.
Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1. However, data regarding the efficacy of this regimen in suppressed persons with history of past resistance or virologic failures is currently insufficient. This is a phase IIa, open-label, single arm, multicentric study.
The hypothesis is that therapy with DTG/3TC would be able to maintain viral control in HIV infected participants with prior history of 3TC resistance but without evidence of M184V/I resistance mutation in proviral DNA population sequencing at baseline. The investigators also hypothesize that archived minority 3TC resistance associated mutations detected by next-generation (NGS) sequencing prior to the switch would not have a significant impact on the efficacy of DTG/3TC.
Read the detailed description
This is a multicentre study, and it will be conducted at different healthcare centres in Spain. 117 participants will be recruited. A minimum of 30%-50% of the study population would be required to have historical RNA population genotype with confirmed M184V/I mutation.
- Conditions
- HIV Infections
- Being tested
- Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]Drug
change of current antiretroviral treatment to DTG 50 mg/3TC 300 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Dovato (Dolutegravir+lamivudine) | Experimental | Treatment: Dolutegravir 50 mg/Lamivudine 300 mg, one film coated-tablet once daily during 96 weeks Receives: Drug: Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of a Switch to DTG/3TC for Maintenance of Virologic Suppression, in Persons With Past Confirmed or Suspected 3TC Resistance, When Proviral DNA Population Sequencing Does Not Detect 3TC Resistance-associated Mutations at Baseline.
There were eight participants with no data at week 48: one LTFU, one protocol deviation (M184V at screening), two investigator decision (1 lung cancer, 1 M184V mutation detected in plasma RNA population genotyping at transient rebound, suppressed with dolutegravir/lamivudine not fulfilling criteria for virologic withdrawal), one consent withdrawal and three withdrawals for AEs.
It was pre-specified to report all participants who discontinued with last available HIV-1 RNA ≥50 copies/mL in "Number of Participants with HIV-1 RNA ≥50 copies/mL" category at week 48.
Measured: Week 48
Secondary outcomes (15)
Estimations of Virological Control
Proportion of VF (≥50 copies/mL) ITT-e, per protocol population (PP), Proportion of VF (≥200 copies/mL), ITT-e and PP population, FDA snapshot. Proportion of Confirmed Virologic Withdrawal ([CVW]: A VL≥ 50 copies/mL followed by a VL≥ 200 copies/mL in retest), ITT-e and PP population, FDA snapshot. Proportion of Precautionary Virologic Withdrawal ([PVW]: three consecutive VL between 50- 200 copies/mL), ITT-e and PP population, FDA snapshot. Proportion of participants with VL<50 copies/mL, ITT-e and per protocol population, FDA snapshot.
Measured: Week 48 and week 96
Viral Resistance in Persons Experiencing VF.
Percentage of VF with drug resistance associated mutations.
- Describe number and type of resistanceassociated mutations in VF
Measured: Throughout all the study, an average of 96 weeks
Time to VF
Due to the low number of events, the analysis of factors associated with VF (i.e., time to VF) was not performed. Additionally, because of the limited number of events, analyses of NGS-related outcomes were conducted only at the 5% level. The pre-specified subgroup analyses were modified and replaced with analyses based on baseline 3TC or FTC use, confirmed prior resistance to 3TC, and prior exposure to INSTIs.
Measured: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroups: Confirmed Historical M184V/I vs No Resistance Mutations
Measured: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroups: INSTI Exposure vs No Prior INSTI Exposure
All participants with M184V/I detected at baseline in proviral DNA NGS had a VL <50 copies/mL at week 48 or last study visit.
Measured: Throughout all the study, an average of 96 weeks
Time Virologically Suppressed
Participants were virologically suppressed for 9 years before the study
Measured: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroup: Time on 3TC/FTC
Measured: Throughout all the study, an average of 96 weeks
Percentage of Participants With VF With Baseline 3TC or INSTI Resistanceassociated Mutations Detected at Baseline by NGS With 1, 5, and 20% Threshold.
Percentage of VF with drug resistance associated mutations and proportion of participants with VF with baseline 3TC or INSTI resistance- associated mutations detected at baseline by NGS with 5% threshold.
Measured: Throughout all the study, an average of 96 weeks
Proportion of Participants With Transient Viral Rebounds With Baseline 3TC or INSTI Resistance- Associated Mutations Detected at Baseline by NGS With 1, 5, and 20% Threshold.
Proportion of participants with transient viral rebounds with baseline 3TC or INSTI resistance- associated mutations detected at baseline by NGS with 5% threshold.
Measured: Throughout all the study, an average of 96 weeks
Number of Participants With M184V/I Presence by Successful Plasma RNA NGS in Participants With Virological Dropout
Next-generation sequencing (NGS) of plasma RNA was successful in one of the two virological withdrawal cases.
Measured: Throughout all the study, an average of 96 weeks
Frequency of Resistance Mutations (RT and Integrase) in Proviral DNA Measured by NGS.
Measured: Throughout all the study, an average of 96 weeks
Change in CD4+ Cell Count
CD4+ count values were observed throughout the 96 weeks.
Measured: Basal, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72 and week 96
Change in CD4+/CD8+ Cell Counts Ratio
Measured: Basal, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72 and week 96
Percentage and Severity of AEs and Laboratory Abnormalities.
Measured: Basal, Week 48 and week 96
Proportion of Subjects Who Discontinue Treatment Due to AEs
Participants who discontinue treatment due to AEs (al week 96)
Measured: Basal, week 48 and week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start28 Jul 2021
- Primary completion12 Jun 2023
- Study completion9 Apr 2024
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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase IIa, open-label, single arm, multicentric study
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880785
- Sponsor's protocol ID
- GESIDA11820
- Acronym
- VOLVER
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2021
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Lagarde M, De Miguel R, Sigcha MA, Blanco JL, Pinto-Martinez A, Montejano R, Gutierrez Liarte A, Navarro-Soler R, Canas-Ruano E, Inciarte A, Martin-Carbonero L, Imaz A, Hernandez Gutierrez C, Ocampo A, de Miguel M, Delgado R, Pulido F, Arribas JR; VOLVER GESIDA 11820 Study Group. Impact of Proviral-DNA M184V/I on 96-Week Outcomes of DTG/3TC Maintenance Therapy: Results From the VOLVER Clinical Trial. Clin Infect Dis. 2026 Jul 23;83(1):149-157. doi: 10.1093/cid/ciag060.
PubMed 41665101
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virologic Outcomes of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine.
- ClinicalTrials.gov ID
- NCT04880785
- Acronym / sponsor ID
- VOLVER / GESIDA11820
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 9 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1. However, data regarding the efficacy of this regimen in suppressed persons with history of past resistance or virologic failures is currently insufficient. This is a phase IIa, open-label, single arm, multicentric study.
The hypothesis is that therapy with DTG/3TC would be able to maintain viral control in HIV infected participants with prior history of 3TC resistance but without evidence of M184V/I resistance mutation in proviral DNA population sequencing at baseline. The investigators also hypothesize that archived minority 3TC resistance associated mutations detected by next-generation (NGS) sequencing prior to the switch would not have a significant impact on the efficacy of DTG/3TC.
Detailed description
This is a multicentre study, and it will be conducted at different healthcare centres in Spain. 117 participants will be recruited. A minimum of 30%-50% of the study population would be required to have historical RNA population genotype with confirmed M184V/I mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase IIa, open-label, single arm, multicentric study
| Arm | Type | Receives |
|---|---|---|
| Dovato (Dolutegravir+lamivudine) | Experimental | Drug: Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]Treatment: Dolutegravir 50 mg/Lamivudine 300 mg, one film coated-tablet once daily during 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults (>=18 years old) with HIV-1 infection able to understand and give informed written consent.
- Stable ART in the 12 weeks prior to screening visit.
- Viral load <50 copies/mL at screening and in the year prior to study entry.
- CD4 count > 200 cel/μL at screening.
- History of 3TC resistance: either confirmed historical 3TC resistance (historical RNA Sanger or RNA NGS>20% threshold genotype with M184V/I mutation) OR suspected historical 3TC resistance.
Key exclusion criteria (14 listed)
- Participants with M184V/I or K65R in screening visit proviral DNA Sanger genotype.
- Prior virologic failure (VF) under integrase inhibitor (INSTI)- based regimen. defined as two consecutive VL > 200 copies/mL while receiving INSTI regardless of genotypic test results
- INSTI resistance mutations in historical RNA genotype.
- Positive Surface Hepatitis B Ag (HBAgS) OR negative HBAgS and negative hepatitis B surface antibody (anti-HBs) with positive anti-core antibody (anti-HBc) and positive HBV DNA.
- Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods (see Appendix 1 for the accepted list of the highly effective methods for avoiding pregnancy), for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
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 |
|---|---|---|
| Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]change of current antiretroviral treatment to DTG 50 mg/3TC 300 mg QD | Drug | Dovato (Dolutegravir+lamivudine) |
Primary outcome
The Efficacy of a Switch to DTG/3TC for Maintenance of Virologic Suppression, in Persons With Past Confirmed or Suspected 3TC Resistance, When Proviral DNA Population Sequencing Does Not Detect 3TC Resistance-associated Mutations at Baseline.
Time frame: Week 48
There were eight participants with no data at week 48: one LTFU, one protocol deviation (M184V at screening), two investigator decision (1 lung cancer, 1 M184V mutation detected in plasma RNA population genotyping at transient rebound, suppressed with dolutegravir/lamivudine not fulfilling criteria for virologic withdrawal), one consent withdrawal and three withdrawals for AEs. It was pre-specified to report all participants who discontinued with last available HIV-1 RNA ≥50 copies/mL in "Number of Participants with HIV-1 RNA ≥50 copies/mL" category at week 48.
15 secondary outcomes
Estimations of Virological Control
Time frame: Week 48 and week 96
Viral Resistance in Persons Experiencing VF.
Time frame: Throughout all the study, an average of 96 weeks
Time to VF
Time frame: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroups: Confirmed Historical M184V/I vs No Resistance Mutations
Time frame: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroups: INSTI Exposure vs No Prior INSTI Exposure
Time frame: Throughout all the study, an average of 96 weeks
Time Virologically Suppressed
Time frame: Throughout all the study, an average of 96 weeks
Proportion of VF in Subgroup: Time on 3TC/FTC
Time frame: Throughout all the study, an average of 96 weeks
Percentage of Participants With VF With Baseline 3TC or INSTI Resistanceassociated Mutations Detected at Baseline by NGS With 1, 5, and 20% Threshold.
Time frame: Throughout all the study, an average of 96 weeks
Proportion of Participants With Transient Viral Rebounds With Baseline 3TC or INSTI Resistance- Associated Mutations Detected at Baseline by NGS With 1, 5, and 20% Threshold.
Time frame: Throughout all the study, an average of 96 weeks
Number of Participants With M184V/I Presence by Successful Plasma RNA NGS in Participants With Virological Dropout
Time frame: Throughout all the study, an average of 96 weeks
Frequency of Resistance Mutations (RT and Integrase) in Proviral DNA Measured by NGS.
Time frame: Throughout all the study, an average of 96 weeks
Change in CD4+ Cell Count
Time frame: Basal, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72 and week 96
Change in CD4+/CD8+ Cell Counts Ratio
Time frame: Basal, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72 and week 96
Percentage and Severity of AEs and Laboratory Abnormalities.
Time frame: Basal, Week 48 and week 96
Proportion of Subjects Who Discontinue Treatment Due to AEs
Time frame: Basal, week 48 and week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41665101De Lagarde M, De Miguel R, Sigcha MA, Blanco JL, Pinto-Martinez A, Montejano R, Gutierrez Liarte A, Navarro-Soler R, Canas-Ruano E, Inciarte A, Martin-Carbonero L, Imaz A, Hernandez Gutierrez C, Ocampo A, de Miguel M, Delgado R, Pulido F, Arribas JR; VOLVER GESIDA 11820 Study Group. Impact of Proviral-DNA M184V/I on 96-Week Outcomes of DTG/3TC Maintenance Therapy: Results From the VOLVER Clinical Trial. Clin Infect Dis. 2026 Jul 23;83(1):149-157. doi: 10.1093/cid/ciag060.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato] in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 17 sites in Spain.
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 10 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Sep 2026). 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?
The Efficacy of a Switch to DTG/3TC for Maintenance of Virologic Suppression, in Persons With Past Confirmed or Suspected 3TC Resistance, When Proviral DNA Population Sequencing Does Not Detect 3TC Resistance-associated Mutations at Baseline. (time frame: Week 48). 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 NCT04880785, 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 9 Sep 2026.