HIV-1-infectionPhase 4RapiDONCT07357584
Efficacy and Safety of Doravirine in the Rapid Initiation
A Phase 4 study testing Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet in people with HIV-1-infection, run by Fundación Huésped at 2 sites in Argentina.
Trial summary
Protocol title: "Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment." Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesArgentina
- Study dates
- 16 Sep 2026to 30 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has to voluntarily signed and dated an informed consent form, approved by an institutional ethics committee.
- ≥18 years of age.
- Not previously exposed to ARV (naïve). Subject may have received oral PrEP and PEP within the last 6 months and injectable PrEP and PEP within the last year.
- Have a received an HIV diagnosis within 30 days prior to selection. Defined as: Having confirmed HIV-1 infection. HIV-1 positive result is considered if the HIV1 RNA in plasma is ≥ 1000 copies/mL or two HIV antibody tests (using two different tests) are positive.
- NOTE: Participants may be included without knowing their baseline viral load. If baseline viral load results are less than 1000 copies/mL, the volunteer's participation will be suspended and they will be considered to have failed the screening test. A viral load brought by the subject may be considered if it was performed within the last 30 days prior to the SCR visit.
- CD4+ T-cell count: No limit.
- Subjects able to meet the protocol requirements.
Who cannot join
- History of hypersensitivity to doravirine, tenofovir, or lamivudine.
- Severe hepatic impairment (Child-Pugh C).
- Active HCV infection requiring specific treatment during study participation at the time of eligibility assessment. If HCV is diagnosed during the study and the participant requires treatment, the decision on whether to continue in the study will be at the investigator's discretion.
- A woman may be eligible to enter and participate in the study if she is not pregnant (confirmed by a negative urine pregnancy test at the time of screening/baseline). If the baseline visit is scheduled on a different day than the SCR, the urine pregnancy test will be repeated) or breastfeeding and if at least one of the following conditions applies:
- Women without reproductive capacity, defined as premenopausal women with tubal ligation or hysterectomy, or documented bilateral oophorectomy; or as postmenopausal women with 12 months of spontaneous amenorrhea, and women ≥ 45 years of age without hormone replacement therapy.
- Women with reproductive capacity who agree to adopt one of the contraceptive options in Appendix 2 for at least 30 days after the last dose of study medication and/or completion of the follow-up visit.
Show all 20Show fewer
- The chosen contraceptive method must be used consistently, according to the approved product label. All study participants must be advised on safer sex practices, including the use of effective barrier methods, and the choice of effective contraceptive method must be documented in the eCRF (Electronic Case Report Form).
- The subject's general health status, in the investigator's oIPnion, interferes with the requirements of the study.
- Has a diagnosis of an active opportunistic infection defining AIDS or a malignant neoplasm within 30 days prior to evaluation (except Kaposi's sarcoma with fewer than 10 skin lesions).
- Is participating or has participated in a clinical study in the last 6 months.
- Creatinine clearance (CrCl) ≤50 mL/min according to the Cockcroft-Gault equation.
- Any verified Grade 4 abnormality (except liIPds: HDL, LDL, total cholesterol, triglycerides).
- History or presence of allergy to study drugs or their components, or to drugs in their class.
- Subjects taking any medication during the study, including over-the-counter medications and herbal preparations, without the approval of the study physician.
- Mutations resistant to doravirine, 3TC, or TDF, according to the list described below:
- DOR mutations (INNTI):
- Doravirine (INNTI) Primary: the presence of one or more ART-resistant mutations will be grounds for exclusion.
- Mutations: V106A/M, F227C/V, L234I, Y188L, Y318F, M230I/L. Secondary: the presence of one or more RAMs will be grounds for exclusion. Mutations: A98G, V108I, G190E, H221Y, P225H, F227L, P236L. Others: the presence of five or more RAMs will be grounds for exclusion. Mutations: V90I, L100I, K101E/H/P, K103N/R/S, V106I, I135T, Y181C/I/V, E138A/G/K/Q/R, V170F/T, G190A/Q/S, Y188C/H, F227I, V245E, K311R.
- NRTI (TDF) Relevant mutations: Presence of one or more RAM Mutations: K65R, insertion 69, K70R/E, Q151M,
- NRTI (3TC) Relevant mutation Presence of IM184V
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina2 sites, 2 recruiting
- Recruiting
Fundacion Huesped
Buenos Aires, C1202ABB
Pedro E Cahn, MD; PhD, (5411) 4981-7777 ext. 21, pcahn@huesped.org.ar
Pedro E Cahn, MD; PhD
- Recruiting
Fundacion IDEAA -Infectologia de atencion ambulatoria
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405CKC
Ezequiel Cordova, MD, 011 49017133, dr_ecordova@hotmail.com
Norma Porteiro, MD, 011 49017133, normaporteiro@yahoo.com.ar
About this study
Official title: Efficacy and Safety of Doravirine in the Rapid Initiation of Highly Active Antiretroviral Therapy (HAART) in HIV-1positive Patients Without Prior Treatment
Protocol title: "Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment."
Read the detailed description
Protocol number: FH-96
Primary objective: To evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV.
Secondary objectives:
- To evaluate the antiviral activity of DOR/3TC/TDF at < 200 coIPes/mL at week 48, using the intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E). 2. To evaluate the antiviral activity of DOR/3TC/TDF at week 48 using an observed analysis (only including patients with available virological data).
- To evaluate the antiviral activity of DOR/3TC/TDF in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, (according to the list of mutations defined in the exclusion criteria) by calculating the proportion of patients with viral load <200 coIPes/mL and <50 coIPes/mL at week 48.
- To evaluate the antiviral activity of DOR/3TC/TDF at <200 coIPes/mL and <50 coIPes/mL at week 24.
- To evaluate the safety and tolerability of DOR/3TC/TDF. 6. To evaluate the antiviral activity of DOR/3TC/TDF at week 48 in patients with a baseline viral load >100,000 coIPes/mL.
- Immune response: to evaluate immune recovery (CD4, CD8 and CD4/CD8 T-cell counts at weeks 24 and 48.
- To evaluate the development of HIV-1 resistance in patients experiencing virological failure while undergoing treatment with DOR/3TC/TDF.
- To assess changes in weight, BMI, and liIPd profile (total cholesterol, HDL, LDL and triglycerides) at weeks 24 and 48.
Study population: Subjects will be HIV-1 infection patient without ARV experience (naïve) within 30 days of diagnosis, willing to start ARV therapy in a rapid initiation setting, with ≥ 18 years of age, and who meet all inclusion criteria and do not meet any of the exclusion criteria.
Study design: Phase IV, multicenter, non-randomized, single-arm, open-label study describing the antiviral efficacy, safety, and tolerability of DOR/3TC/TDF therapy as rapid initiation therapy in subjects with HIV-1 infection who have not received prior treatment.
Regimens: Doravirine 100 mg; Lamivudine 300 mg; Tenofovir disoproxil 245 mg. Thirteen bottles. (Trade name: DELSTRIGO - MSD). Duration: 48 weeks.
Sample size: 100 subjects
- Conditions
- HIV-1-infection
- Being tested
- Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet
- Keywords
- Efficacy, Safety, Doravirine, Rapid initiation of highly active antiretroviral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doravirine / lamivudine/ Tenofovir Disoproxil Oral TabletDrug
Also called Delstrigo
Pharmaceutical form: Oral tablets Unit dose concentration/dose level(s): 100/300/245 mg Administration instructions: Take one tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| Doravirine /Lamivudine/ Tenofovir Disoproxil | Experimental | Doravirine 100 mg/Lamivudine 300 mg/Tenofovir disoproxilo245 mg Receives: Drug: Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV patients without prior antiretroviral treatment, in a rapid initiation setting.
Proportion of patients with a viral load < 50 copies/mL at week 48, as determined by an intention-to-treat analysis (FDA snapshot analysis) of the exposed population (ITT-E)
Measured: 48 Weeks
Secondary outcomes (10)
Evaluate the antiviral activity of DOR/3TC/TDF at < 200 copies/mL at week 48, using the intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).
Proportion of patients with a viral load < 200 copies/mL at week 48, using intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).
Measured: 48 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 using an observed analysis (only including patients with available virological data).
Proportion of patients who achieved HIV-1 RNA levels <50 copies/mL at week 48, in those with available data (observed analysis)
Measured: 48 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, by calculating the proportion of patients with viral load <200 c/mL and <50 c/mL at week 48.
Proportion of patients with viral load < 200 copies/mL and viral load < 50 copies/mL at week 48 in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, according to the list of mutations defined in the exclusion criteria.
Measured: 48 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF at <200 copies/mL and <50 copies/mL at week 24.
Proportion of patients with viral load < 200 copies/mL and viral load < 50 copies/mL at week 24, using intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).
Measured: 24 Weeks
Evaluate the safety and tolerability of DOR/3TC/TDF.
Frequency, type, severity, and seriousness of adverse events and laboratory abnormalities, and proportion of patients who discontinued treatment with DOR/3TC/TDF due to adverse events or death
Measured: 52 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in patients with a baseline viral load >100,000 copies/mL.
Proportion of patients with a baseline HIV-1 RNA level >100,000 c/mL who achieve virological suppression below 50 copies/mL at week 48 (ITT-E analysis).
Measured: 48 Weeks
Immune response: evaluate immune recovery (CD4, CD8 and CD4/CD8 T-cell counts at weeks 24 and 48.
Changes in CD4 T-cell count, CD8 T-cell count, and CD4/CD8 ratio between baseline and weeks 24 and 48.
Measured: 24 and 48 Weeks
Evaluate the development of HIV-1 resistance in patients experiencing virological failure while undergoing treatment with DOR/3TC/TDF
Number and type of resistance mutations in cases of virological failure.
Measured: 48 Weeks
Assess changes in weight and BMI, at weeks 24 and 48.
Changes in weight and BMI between baseline and weeks 24 and 48. Weight and height will be combined to calculate BMI in kg/m^2. Weight will be measured at all visits and height only at the baseline visit.
Measured: 24 and 48 Weeks
Assess changes in lipid profile (total cholesterol, HDL, LDL and triglycerides) at weeks 24 and 48.
Changes in lipid profile (total cholesterol, HDL, LDL and triglycerides) between baseline and weeks 24 and 48.
Measured: 24 and 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start16 Sep 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, non-randomized, single-arm, non-comparative, open-label study design
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC, Fundacion IDEAA
- Responsible party
- Principal investigator, Pedro Enrique Cahn, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357584
- Sponsor's protocol ID
- FH-96
- Acronym
- RapiDO
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be shared upon request, 6 months after last patient´s last visit. URL not yet available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Doravirine in the Rapid Initiation of Highly Active Antiretroviral Therapy (HAART) in HIV-1positive Patients Without Prior Treatment
- ClinicalTrials.gov ID
- NCT07357584
- Acronym / sponsor ID
- RapiDO / FH-96
- Conditions
- HIV-1-infection
- Keywords
- Efficacy, Safety, Doravirine, Rapid initiation of highly active antiretroviral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC, Fundacion IDEAA
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Jan 2026 (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.
Protocol title: "Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment."
Detailed description
Protocol number: FH-96
Primary objective: To evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV.
Secondary objectives:
- To evaluate the antiviral activity of DOR/3TC/TDF at < 200 coIPes/mL at week 48, using the intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E). 2. To evaluate the antiviral activity of DOR/3TC/TDF at week 48 using an observed analysis (only including patients with available virological data).
- To evaluate the antiviral activity of DOR/3TC/TDF in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, (according to the list of mutations defined in the exclusion criteria) by calculating the proportion of patients with viral load <200 coIPes/mL and <50 coIPes/mL at week 48.
- To evaluate the antiviral activity of DOR/3TC/TDF at <200 coIPes/mL and <50 coIPes/mL at week 24.
- To evaluate the safety and tolerability of DOR/3TC/TDF. 6. To evaluate the antiviral activity of DOR/3TC/TDF at week 48 in patients with a baseline viral load >100,000 coIPes/mL.
- Immune response: to evaluate immune recovery (CD4, CD8 and CD4/CD8 T-cell counts at weeks 24 and 48.
- To evaluate the development of HIV-1 resistance in patients experiencing virological failure while undergoing treatment with DOR/3TC/TDF.
- To assess changes in weight, BMI, and liIPd profile (total cholesterol, HDL, LDL and triglycerides) at weeks 24 and 48.
Study population: Subjects will be HIV-1 infection patient without ARV experience (naïve) within 30 days of diagnosis, willing to start ARV therapy in a rapid initiation setting, with ≥ 18 years of age, and who meet all inclusion criteria and do not meet any of the exclusion criteria.
Study design: Phase IV, multicenter, non-randomized, single-arm, open-label study describing the antiviral efficacy, safety, and tolerability of DOR/3TC/TDF therapy as rapid initiation therapy in subjects with HIV-1 infection who have not received prior treatment.
Regimens: Doravirine 100 mg; Lamivudine 300 mg; Tenofovir disoproxil 245 mg. Thirteen bottles. (Trade name: DELSTRIGO - MSD). Duration: 48 weeks.
Sample size: 100 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, non-randomized, single-arm, non-comparative, open-label study design
| Arm | Type | Receives |
|---|---|---|
| Doravirine /Lamivudine/ Tenofovir Disoproxil | Experimental | Drug: Doravirine / lamivudine/ Tenofovir Disoproxil Oral TabletDoravirine 100 mg/Lamivudine 300 mg/Tenofovir disoproxilo245 mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has to voluntarily signed and dated an informed consent form, approved by an institutional ethics committee.
- ≥18 years of age.
- Not previously exposed to ARV (naïve). Subject may have received oral PrEP and PEP within the last 6 months and injectable PrEP and PEP within the last year.
- Have a received an HIV diagnosis within 30 days prior to selection. Defined as: Having confirmed HIV-1 infection. HIV-1 positive result is considered if the HIV1 RNA in plasma is ≥ 1000 copies/mL or two HIV antibody tests (using two different tests) are positive.
- NOTE: Participants may be included without knowing their baseline viral load. If baseline viral load results are less than 1000 copies/mL, the volunteer's participation will be suspended and they will be considered to have failed the screening test. A viral load brought by the subject may be considered if it was performed within the last 30 days prior to the SCR visit.
Key exclusion criteria (20 listed)
- History of hypersensitivity to doravirine, tenofovir, or lamivudine.
- Severe hepatic impairment (Child-Pugh C).
- Active HCV infection requiring specific treatment during study participation at the time of eligibility assessment. If HCV is diagnosed during the study and the participant requires treatment, the decision on whether to continue in the study will be at the investigator's discretion.
- A woman may be eligible to enter and participate in the study if she is not pregnant (confirmed by a negative urine pregnancy test at the time of screening/baseline). If the baseline visit is scheduled on a different day than the SCR, the urine pregnancy test will be repeated) or breastfeeding and if at least one of the following conditions applies:
- The chosen contraceptive method must be used consistently, according to the approved product label. All study participants must be advised on safer sex practices, including the use of effective barrier methods, and the choice of effective contraceptive method must be documented in the eCRF (Electronic Case Report Form).
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 |
|---|---|---|
| Doravirine / lamivudine/ Tenofovir Disoproxil Oral TabletAlso: DelstrigoPharmaceutical form: Oral tablets Unit dose concentration/dose level(s): 100/300/245 mg Administration instructions: Take one tablet once a day | Drug | Doravirine /Lamivudine/ Tenofovir Disoproxil |
Primary outcome
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV patients without prior antiretroviral treatment, in a rapid initiation setting.
Time frame: 48 Weeks
Proportion of patients with a viral load < 50 copies/mL at week 48, as determined by an intention-to-treat analysis (FDA snapshot analysis) of the exposed population (ITT-E)
10 secondary outcomes
Evaluate the antiviral activity of DOR/3TC/TDF at < 200 copies/mL at week 48, using the intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).
Time frame: 48 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 using an observed analysis (only including patients with available virological data).
Time frame: 48 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, by calculating the proportion of patients with viral load <200 c/mL and <50 c/mL at week 48.
Time frame: 48 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF at <200 copies/mL and <50 copies/mL at week 24.
Time frame: 24 Weeks
Evaluate the safety and tolerability of DOR/3TC/TDF.
Time frame: 52 Weeks
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in patients with a baseline viral load >100,000 copies/mL.
Time frame: 48 Weeks
Immune response: evaluate immune recovery (CD4, CD8 and CD4/CD8 T-cell counts at weeks 24 and 48.
Time frame: 24 and 48 Weeks
Evaluate the development of HIV-1 resistance in patients experiencing virological failure while undergoing treatment with DOR/3TC/TDF
Time frame: 48 Weeks
Assess changes in weight and BMI, at weeks 24 and 48.
Time frame: 24 and 48 Weeks
Assess changes in lipid profile (total cholesterol, HDL, LDL and triglycerides) at weeks 24 and 48.
Time frame: 24 and 48 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided. It will be shared upon request, 6 months after last patient´s last visit. URL not yet available.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet in people with HIV-1-infection, run by Fundación Huésped at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 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: looking for participants now, as of the sponsor's last update on 23 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 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro E Cahn, MD (1121209999 ext. 2007, pedro.cahn@huesped.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV patients without prior antiretroviral treatment, in a rapid initiation setting. (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 23 Sep 2026.