HIV-1-infectionPhase 2/3NCT03902522
PRO 140 in Treatment-Experienced HIV-1 Subjects
A Phase 2/3 study testing PRO 140 in people with HIV-1-infection, run by CytoDyn, Inc. at 17 sites in United States.
Trial summary
The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART (antiretroviral therapy) during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment… 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?
- PRO 140
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 17 sitesUnited States
- Study dates
- 25 Jun 2018to 18 May 2020
- Phase
- Phase 2/3
- 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
- Males and females, age ≥18 years
- Exclusive CCR5-tropic virus at Screening Visit as determined by Monogram Biosciences Trofile® Assay
- Have a history of at least 3 months on current antiretroviral regimen
- Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within three drug classes OR Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within two drug classes and have limited treatment option. The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs.
- Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
- Plasma HIV-1 RNA ≥ 400 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Roche Taqman® Real-Time PCR) and documented detectable viral load (HIV-1 RNA >50 copies/ml) within the last 3 months prior to Screening Visit
Show all 17Show fewer
- Laboratory values at Screening of:
- Absolute neutrophil count (ANC) ≥750/mm3
- Hemoglobin (Hb) ≥10.5 gm/dL (male) or ≥ 9.5 gm/dL (female)
- Platelets ≥75,000 /mm3
- Serum alanine transaminase (SGPT/ALT) <5 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) <5 x ULN
- Bilirubin (total) <2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
- Creatinine ≤1.5 x ULN
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator
- Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug
- Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent Note: Subjects diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) may be enrolled if in the opinion of site investigator these circumstances would not interfere with the subject's successful completion of the study requirements
Who cannot join
- Documented CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by HIV-1 tropism assay
- Patients with no viable treatment options ( i.e., no fully active antiretroviral drug available which can be effectively combined to form a viable new OBT)
- Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma) Note: Subjects infected by the hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria
- Laboratory test values of ≥ grade 3 DAIDS (Division of Acquired Immune Deficiency Syndrome) laboratory abnormality with the exception of the absolute CD4+ count criterion of <200/mm3
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Unexplained fever or clinically significant illness within 1 week prior to the first study dose
Show all 19Show fewer
- Any vaccination within 2 weeks prior to the first study dose
- Subjects weighing < 35kg
- History of anaphylaxis to oral or parenteral drugs
- History of Bleeding Disorder or patients on anti-coagulant therapy
- Participation in an experimental drug trial(s) within 30 days of the Screening Visit
- Any known allergy or antibodies to the study drug or excipients
- Treatment with any of the following:
- Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
- Immunosuppressants within 60 days prior to the screening visit
- Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
- Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy >5 mg/day will be excluded with the following exception:
- Subjects on inhaled, nasal, or topical steroids will not be excluded
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
CD02_OpenLabel Investigational Site
Bellaire, Texas, 77301
CD02_OpenLabel Investigational Site
Chicago, Illinois, 60613
CD02_OpenLabel Investigational Site
Decatur, Georgia, 30033
CD02_OpenLabel Investigational Site
Ft. Pierce, Florida, 34982
CD02_OpenLabel Investigational Site
Houston, Texas, 77004
CD02_OpenLabel Investigational Site
Houston, Texas, 77098
CD02_OpenLabel Investigational Site
Miami, Florida, 33136
CD02_OpenLabel Investigational Site
Miami, Florida, 33139
CD02_OpenLabel Investigational Site
Miami, Florida, 33169
CD02_OpenLabel Investigational Site
New Haven, Connecticut, 06510
CD02_OpenLabel Investigational Site
Orlando, Florida, 32803
CD02_OpenLabel Investigational Site
Palm Springs, California, 92262
CD02_OpenLabel Investigational Site
San Francisco, California, 94115
CD02_OpenLabel Investigational Site
Spokane, Washington, 99202
CD02_OpenLabel Investigational Site
Syracuse, New York, 13210
CD02_OpenLabel Investigational Site
West Palm Beach, Florida, 33401
CD02_OpenLabel Investigational Site
Wichita, Kansas, 67214
About this study
Official title: A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects
The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART (antiretroviral therapy) during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.
Read the detailed description
PRO 140, in combination with other antiretroviral agents, is indicated for treatment experienced adult HIV-1 patients infected with CCR5-tropic virus (virus that uses the chemokine receptor type 5 to enter the cell). These patients must demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy and have documented genotypic or phenotypic resistance to at least one ART drug within three drug classes (or within two or more drug classes with limited treatment option). The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two drug classes with limited treatment option). The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.
- Conditions
- HIV-1-infection
- Being tested
- PRO 140
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO 140Drug
Also called Leronlimab
2 injections of PRO 140 (2 X 2 mL/inj.) Subjects who were previously enrolled and receiving 350 mg dose had the option to move to the 700mg dose for the remainder of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Leronlimab (PRO 140) | Experimental | Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly subcutaneous (SC) Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Receives: Drug: PRO 140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period
The primary endpoint for this study is the proportion of participants with a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline to the end of the initial 1-week treatment period.
Measured: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
Secondary outcomes (7)
Proportion of Participants With ≥ 1 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period
The secondary endpoint is the proportion of participants with ≥ 1 log10 reduction in HIV-1 RNA viral load from baseline at the end of the initial 1-week treatment period
Measured: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the Initial 1-week Treatment Period
The secondary endpoint is the mean change between baseline and the end of the 1-week of treatment period in HIV-1 RNA levels (log10 copies/mL) (baseline was T1, mean change was calculated between time points T1 and T2).
If the mean change is a negative value, this indicates a reduction in viral load.
Measured: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25
The secondary endpoint is the percentage of participants achieving HIV-1 RNA < 400 copies/mL at week 25
Measured: 25 weeks post-initiation of PRO 140 and existing ART treatment
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25
The secondary outcome measure is the percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 25
Measured: 25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL)
The secondary outcome measure is the mean change in HIV-1 RNA levels (log10 copies/mL) between Baseline (T1) and week 25 (T25). Baseline was T1, mean change was calculated between time points T1 and T25.
If the mean change is a negative value, this indicates a reduction in viral load.
Measured: 25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in CD4 Cell Count at the End of the Initial 1-week Treatment Period
The secondary outcome measure is the mean change in CD4 cell count between Baseline and the end of the initial 1-week treatment period (T2). Baseline was T1, mean change was calculated between time points T1 and T2.
Measured: 1-week post-initiation of PRO 140 and ART treatment.
Mean Change From Baseline in CD4 Cell Count at Week 23
The secondary outcome measure is the mean change in CD4 cell count between Baseline (T1) and week 23 (T23)
Measured: 23 weeks post-initiation of PRO 140 and existing ART treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start25 Jun 2018
- Primary completion18 May 2020
- Study completion18 May 2020
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoDyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Scott Kelly, MD, Study chair, CytoDyn, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902522
- Sponsor's protocol ID
- PRO 140_CD02_OpenLabel
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2019
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects
- ClinicalTrials.gov ID
- NCT03902522
- Acronym / sponsor ID
- PRO 140_CD02_OpenLabel
- Conditions
- HIV-1-infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CytoDyn, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART (antiretroviral therapy) during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.
Detailed description
PRO 140, in combination with other antiretroviral agents, is indicated for treatment experienced adult HIV-1 patients infected with CCR5-tropic virus (virus that uses the chemokine receptor type 5 to enter the cell). These patients must demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy and have documented genotypic or phenotypic resistance to at least one ART drug within three drug classes (or within two or more drug classes with limited treatment option). The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two drug classes with limited treatment option). The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leronlimab (PRO 140) | Experimental | Drug: PRO 140Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly subcutaneous (SC) Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females, age ≥18 years
- Exclusive CCR5-tropic virus at Screening Visit as determined by Monogram Biosciences Trofile® Assay
- Have a history of at least 3 months on current antiretroviral regimen
- Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within three drug classes OR Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within two drug classes and have limited treatment option. The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs.
- Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
Key exclusion criteria (19 listed)
- Documented CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by HIV-1 tropism assay
- Patients with no viable treatment options ( i.e., no fully active antiretroviral drug available which can be effectively combined to form a viable new OBT)
- Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma) Note: Subjects infected by the hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria
- Laboratory test values of ≥ grade 3 DAIDS (Division of Acquired Immune Deficiency Syndrome) laboratory abnormality with the exception of the absolute CD4+ count criterion of <200/mm3
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant 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 |
|---|---|---|
| PRO 140Also: Leronlimab2 injections of PRO 140 (2 X 2 mL/inj.) Subjects who were previously enrolled and receiving 350 mg dose had the option to move to the 700mg dose for the remainder of the trial. | Drug | Leronlimab (PRO 140) |
Primary outcome
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period
Time frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
The primary endpoint for this study is the proportion of participants with a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline to the end of the initial 1-week treatment period.
7 secondary outcomes
Proportion of Participants With ≥ 1 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period
Time frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the Initial 1-week Treatment Period
Time frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25
Time frame: 25 weeks post-initiation of PRO 140 and existing ART treatment
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25
Time frame: 25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL)
Time frame: 25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in CD4 Cell Count at the End of the Initial 1-week Treatment Period
Time frame: 1-week post-initiation of PRO 140 and ART treatment.
Mean Change From Baseline in CD4 Cell Count at Week 23
Time frame: 23 weeks post-initiation of PRO 140 and existing ART treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Scott Kelly, MD study chair
CytoDyn, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRO 140 in people with HIV-1-infection, run by CytoDyn, Inc. at 17 sites 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 17 inclusion and 19 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 16 Sep 2025. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Yes. Results are posted in the registry (first posted 16 Sep 2025). 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?
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period (time frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period). 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 16 Sep 2025.