Human Immunodeficiency VirusPhase 1NCT03307915
A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment
A Phase 1 study testing Ad26.Mos4.HIV, MVA-Mosaic and Clade C gp140 + Mosaic gp140 in people with Human Immunodeficiency Virus, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.
Trial summary
The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Ad26.Mos4.HIV, MVA-Mosaic and Clade C gp140 + Mosaic gp140
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 5 Nov 2021
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Each participant must have documented Human immunodeficiency virus type1 (HIV-1) infection
- Each participant must be on suppressive antiretroviral treatment (ART) for at least 48 weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability reasons only until 4 weeks prior to screening
- Each participant must have started ART outside of the acute or early phase of infection
- Each participant must have a plasma HIV ribonucleic acid (RNA) less than (<) 50 copies/ milliliter (mL) at screening and at least one documented evidence of plasma HIV RNA <50 copies/mL after the last ART change. In case of ART change within the 48 weeks prior randomization, at least one additional more recent documented plasma HIV RNA <50 copies/mL is required. One blip of HIV RNA greater than (>)50 and <200 copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most recent (after last ART change, tested before and/or during screening) HIV RNA results are <50 copies/mL
- Each participant must be medically stable as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
Who cannot join
- Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study, or within 3 months after the last vaccination
- Anyone with contraindication to intramuscular injections and blood draws example, bleeding disorders
- Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºC (degree centigrade) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Anyone with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Anyone with a history of Acquired Immunodeficiency Syndrome (AIDS)-defining illness according to Centers for Disease Control and prevention (CDC) criteria based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with AIDS-defining illnesses assessed by the investigator as clinically irrelevant must be provided to the sponsor and Protocol Safety Review Team (PSRT), who will determine eligibility on a case-by-case basis prior to randomization
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- Anyone with a history of CD4+ less than (<) 200 cells per millimeter cube (cells/mm^3), based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with history of CD4+ <200 cells/mm^3 assessed by the investigator as clinically irrelevant must be provided to the sponsor and PSRT, who will determine eligibility on a case-by-case basis prior to randomization
- Anyone with chronic active hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] antibody test; if positive, HCV RNA polymerase chain reaction test will be used to confirm active versus past HCV infection) or syphilis infection that has not been effectively treated. Positive syphilis serology due to past effectively treated infection is not exclusionary
- Anyone who received or plans to receive: a) licensed live attenuated vaccines within 28 days before or after planned administration of any of the study vaccinations; b) other licensed (not live) vaccines - within 14 days before or after planned administration of any of the study vaccinations
- Anyone who received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine. Receipt of prophylactic or therapeutic HIV vaccine candidate at any time is always exclusionary. Exceptions: Participants can be included where the vaccine received was subsequently licensed. Participants with proof of having received only a placebo vaccine can also be included
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With MVA-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in HIV-1 Infected Adults on Suppressive ART
The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Ad26.Mos4.HIV, MVA-Mosaic, Clade C gp140 + Mosaic gp140, Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.Mos4.HIVBiological
Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.
MVA-MosaicBiological
Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36.
Clade C gp140 + Mosaic gp140Biological
Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.
PlaceboDrug
Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo | Experimental | Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections). Receives: Biological: Ad26.Mos4.HIV; Biological: MVA-Mosaic; Drug: Placebo |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Experimental | Participants will receive Ad26.Mos4.HIV, 5*10^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5*10^10 vp plus Clade C gp140 (125 microgram [mcg]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections). Receives: Biological: Ad26.Mos4.HIV; Biological: Clade C gp140 + Mosaic gp140 |
| Group 3: Placebo | Placebo comparator | Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Measured: 7 days post-vaccination (approximately up to 37 weeks)
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
Measured: 7 days post-vaccination (approximately up to 37 weeks)
Percentage of Participants With AEs as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Approximately up to 96 weeks
Secondary outcomes (6)
Total IgG and Subclass Specific Antibody Titer
Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
Measured: Up to post-vaccination follow-up period until Week 96
Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)
Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay.
Measured: Up to post-vaccination follow-up period until Week 96
Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay
Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited.
Measured: Up to post-vaccination follow-up period until Week 96
Functionality of T-cell Responses as Measured by ICS Assay
ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited.
Measured: Up to post-vaccination follow-up period until Week 96
Phenotype of T-cell Responses as Measured by ICS Assay
ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited.
Measured: Up to post-vaccination follow-up period until Week 96
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Measured: Up to post-vaccination follow-up period until Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start5 Mar 2018
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center, Ragon Institute of MGH, MIT and Harvard, US Military HIV Research Program
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307915
- Sponsor's protocol ID
- CR108372
- Other IDs
- VAC89220HTX1002, IPCAVD-013
- Status last verified
- Jan 2025
- First submitted
- 25 Sep 2017
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With MVA-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in HIV-1 Infected Adults on Suppressive ART
- ClinicalTrials.gov ID
- NCT03307915
- Acronym / sponsor ID
- CR108372
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center, Ragon Institute of MGH, MIT and Harvard, US Military HIV Research Program
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 12 Oct 2017 (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.
The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo | Experimental | Biological: Ad26.Mos4.HIV, Biological: MVA-Mosaic, Drug: PlaceboParticipants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections). |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Experimental | Biological: Ad26.Mos4.HIV, Biological: Clade C gp140 + Mosaic gp140Participants will receive Ad26.Mos4.HIV, 5*10^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5*10^10 vp plus Clade C gp140 (125 microgram [mcg]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections). |
| Group 3: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Each participant must have documented Human immunodeficiency virus type1 (HIV-1) infection
- Each participant must be on suppressive antiretroviral treatment (ART) for at least 48 weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability reasons only until 4 weeks prior to screening
- Each participant must have started ART outside of the acute or early phase of infection
- Each participant must have a plasma HIV ribonucleic acid (RNA) less than (<) 50 copies/ milliliter (mL) at screening and at least one documented evidence of plasma HIV RNA <50 copies/mL after the last ART change. In case of ART change within the 48 weeks prior randomization, at least one additional more recent documented plasma HIV RNA <50 copies/mL is required. One blip of HIV RNA greater than (>)50 and <200 copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most recent (after last ART change, tested before and/or during screening) HIV RNA results are <50 copies/mL
- Each participant must be medically stable as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
Key exclusion criteria (10 listed)
- Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study, or within 3 months after the last vaccination
- Anyone with contraindication to intramuscular injections and blood draws example, bleeding disorders
- Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºC (degree centigrade) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Anyone with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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 |
|---|---|---|
| Ad26.Mos4.HIVParticipants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2. | Biological | Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo, Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 |
| MVA-MosaicParticipants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36. | Biological | Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo |
| Clade C gp140 + Mosaic gp140Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36. | Biological | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 |
| PlaceboParticipants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3. | Drug | Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo, Group 3: Placebo |
Primary outcome
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: 7 days post-vaccination (approximately up to 37 weeks)
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Time frame: 7 days post-vaccination (approximately up to 37 weeks)
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
Percentage of Participants With AEs as a Measure of Safety and Tolerability
Time frame: Approximately up to 96 weeks
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
6 secondary outcomes
Total IgG and Subclass Specific Antibody Titer
Time frame: Up to post-vaccination follow-up period until Week 96
Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)
Time frame: Up to post-vaccination follow-up period until Week 96
Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay
Time frame: Up to post-vaccination follow-up period until Week 96
Functionality of T-cell Responses as Measured by ICS Assay
Time frame: Up to post-vaccination follow-up period until Week 96
Phenotype of T-cell Responses as Measured by ICS Assay
Time frame: Up to post-vaccination follow-up period until Week 96
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Time frame: Up to post-vaccination follow-up period until Week 96
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad26.Mos4.HIV, MVA-Mosaic and Clade C gp140 + Mosaic gp140 in people with Human Immunodeficiency Virus, run by Janssen Vaccines & Prevention B.V. at 1 site in United States.
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 10 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: 7 days post-vaccination (approximately up to 37 weeks)). The study lists 3 primary outcomes in all. 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 4 Feb 2025.