HIV/AIDSPhase 2NCT04505501
Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection
A Phase 2 study testing N-803 in people with HIV/AIDS, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
Reducing HIV persistence in lymph nodes by Interleukin-15 (IL-15) Receptor super-agonist (N-803) in Individuals with Acute HIV Infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- N-803
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2021to 30 Jun 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above.
- Acute HIV infection (Fiebig I to V: Fiebig I: RNA+, p24 antigen-; Fiebig II: p24 antigen+, IgM-; Fiebig III: IgM+, Western Blot-; Fiebig IV: Western Blot indeterminate; Fiebig V: Western Blot+ without p31 protein band)
- All female participants of childbearing potential must have a negative urine pregnancy test at the screening visit
- Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception (as defined in section 8.1.2 Pregnancy Risks) during therapy and for 4 months after completion of therapy
- Can read and write Thai and/or English language and must be able to understand and complete the informed consent process
- Must successfully complete a Test of Understanding (TOU) prior to enrollment as described in Section 7.1
Show all 19Show fewer
- Willing to undergo inguinal LN Bx at two time points (baseline and week 6) and blood draws during each study visit
- Willing to participate for the duration of the study visits and follow up.
- Completed Step 1 as per protocol
- Plasma HIV-1 RNA <50 copies/mL at the Step 2 screening visit
- CD4 T-cell count ≥400 cells/mm3 at the Step 2 screening visit Note: The CD4 T-cell count can be repeated once, provided that the repeat is done within 1 week prior to Step 2 entry.
- No CDC Category C event after study entry
- Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) at the screening Step 2 visit.
- Documented negative hepatitis C virus (HCV) antibody (anti-HCV) or negative HCV RNA (if anti-HCV reactive) at the Step 2 screening visit
- For persons of childbearing potential, negative pregnancy test at the Step 2 screening visit.
- Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy. One contraceptive method must be from the list of highly effective methods listed in section 7.12. The second method of contraception must be from the barrier methods also listed in section 7.13.
- Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.
- Willingness to participate in ATI for up to 12 weeks.
- Willingness to restart ART according to study guidelines.
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
- Receipt of any vaccine within 2 weeks prior to study enrollment and anticipated need for any vaccine within 2 weeks prior to or after any of the study agent administrations.
- Current or anticipated use of systemic steroid medications.
- Any clinically significant acute or chronic medical condition, including, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiac disease, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.)
- Chronic liver disease
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- Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: (a) acute myocardial infarction, (b) acute coronary syndromes, (c) stable or unstable angina, (d) coronary or other arterial revascularization, (e) stroke, (f) transient ischemic attack, or (g) peripheral arterial disease presumed to be of atherosclerotic origin
- History of potential immune-mediated medical conditions
- Serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment
- Major psychiatric illness and/or substance use during the past 12 months that in the opinion of the investigator would preclude participation
- Concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment
- Exposure to any experimental therapies within 90 days of study entry
- Pre-exposure prophylaxis (PrEP) use within 90 days of study entry
- Virologic failure (two consecutive HIV-1 RNA >1000 copies/mL)
- Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.
- Receipt of any non-nucleoside reverse transcriptase inhibitor (NNRTI) within 60 days before Step 2 entry.
- Receipt of long-acting ART such as long-acting cabotegravir (CAB LA) or long-acting rilpivirine (RPV LA) at any point after study entry.
- Failure by the participant to attend three consecutive Step 1 study visits.
- Pregnancy or breastfeeding.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Individuals With Acute HIV Infection
Reducing HIV persistence in lymph nodes by Interleukin-15 (IL-15) Receptor super-agonist (N-803) in Individuals with Acute HIV Infection
Read the detailed description
This is a phase II, randomized, unblinded, controlled trial to investigate the safety, tolerability and immunomodulation effect of combining N-803 with ART during AHI. The study will be conducted at the Thai Red Cross AIDS Research Centre (TRCARC)/King Chulalongkorn Memorial Hospital and the Faculty of Medicine, Chulalongkorn University in Bangkok, Thailand.
Eligible participants will be asked to undergo LN Bx at baseline (untreated AHI), prior to initiating dolutegravir-based ART.
This study will have three steps.
In Step 1, N-803 will be administered subcutaneously at weeks 0, 3, 6 (total 3 doses) and will be initiated together with ART. Participants will be asked to undergo a second inguinal LN Bx on the opposite groin approximately at week 6 (no later than 1 week after completion of study agents). They will be followed for safety parameters at weeks 8 and 12, after which they will roll over to the RV412, WRAIR#2178 safety monitoring protocol. Step 1 duration for individual participants will be approximately 12 weeks. Step 1 has been completed as per protocol by 12 participants, 8 N-803 recipients and 4 ART only participants and study recruitment has ended.
In Step 2, participants who have completed Step 1 as per protocol and remain virologically controlled will be given a single dose of N-803 followed by ATI. The N-803 dose will be offered to all these participants regardless of initial randomization in Step 1. In Step 2, N-803 will be administered at Step 2 week 0 followed by ATI on the same day. The participants will be followed during ATI for viral rebound and monitored for the restart criteria for a maximum of 12 weeks. Participants who do not meet ART restart criteria at the end of Step 2 will proceed to RV412, WRAIR#2178 for safety follow-up.
In Step 3, participants who did restart ART during Step 2 will be monitored for safety after restarting ART. Participants will be monitored every 2 weeks for a total of 12 weeks in Step 3. Any participants who may not have achieved HIV suppression by the end of Step 3 and the study will also proceed to RV412, WRAIR#2178 for continuing safety follow-up. Total study duration through data analysis and closure is estimated at five years.
It is hypothesized that N-803 initiated with ART during AHI, will be safe, and will lead to a reduction of HIV reservoir size in LN, demonstrated by decreased frequencies of vRNA+ and vDNA+ cells in the LNs, in comparison with ART alone.
- Conditions
- HIV/AIDS
- Being tested
- N-803
- 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.
N-803Drug
Also called ALT-803
N-803 is a novel IL-15 superagonist complex that enhances NK cell and CD8+ T-cell proliferation and activation.
| Study group | Role | What they receive |
|---|---|---|
| N-803 | Experimental | Step 1: N-803 at 6mcg/kg every 3 weeks for 3 doses plus ART (n=10) Step 2 : N-803 at 6mcg/kg at week 0 single dose (n=8), ATI after N-803 injection until week 12 (If meet criteria to restart ART, participants will go to step 3).
Step 3: ART restart (week 0 to week 12). Receives: Drug: N-803 |
| Control | No intervention | Step 1: ART alone (n=5) Step 2 : N-803 at 6mcg/kg at week 0 single dose (n=8), ATI after N-803 injection until week 12 (If meet criteria to restart ART, participants will go to step 3). Step 3: ART restart (week 0 to week 12). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of ≥ grade 3 adverse events determined to be related (Safety)
Rate of occurrence of ≥ grade 3 adverse events determined to be related
Measured: at time of study completion at week 12
Frequency of vRNA+ and vDNA+ cells and levels of vDNA and vRNA in LNs
Frequency of vRNA+ and vDNA+ cells and levels of vDNA and vRNA in LNs
Measured: At baseline (week 0) and week 6
Frequency, phenotype and function of CD8+ T cells and innate cells in LNs
Frequency, phenotype and function of CD8+ T cells and innate cells in LNs
Measured: At baseline (week 0) and week 6
Time (days) from ATI to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL following ATI.
Time (days) from ATI to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL following ATI.
Measured: viral rebound during Step 2 ATI
Secondary outcomes (9)
Frequency, phenotype and function of NK, T, B and other immune cells in LNs and blood
Frequency, phenotype and function of NK, T, B and other immune cells in LNs and blood
Measured: Step 1 weeks 0, 3, 6, 12; Step 2 weeks 0, 2, 4, 6, 8, 10; Step 3 weeks 0, 2, 4, 6, 8, 10, 12
HIV-specific antibody levels and ADCC, ADCP, ADCVI activities
HIV-specific antibody function as measured by Antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and Antibody-dependent cell-mediated viral inhibition (ADCVI) levels.
Measured: Step 1 weeks 0, 3, 6, 12; Step 2 weeks 0, 2, 4, 6, 8, 10; Step 3 weeks 0, 2, 4, 6, 8, 10, 12
Frequency of cells harboring HIV-1 vDNA, vRNA, intact genome and replication competent HIV-1 in PBMC
Frequency of cells harboring HIV-1 vDNA, vRNA, intact genome and replication competent HIV-1 in PBMC
Measured: Step 1 weeks 0, 3, 6, 12; Step 2 week 0; Step 3 week 12
Host and viral genes by transcriptome analysis
Host and viral genes by transcriptome analysis
Measured: Step 1 week 0 and 6
Immune activation markers in blood
Immune activation markers in blood
Measured: Step 1 weeks 0, 3, 6, 12; Step 2 weeks 0, 2, 4, 6, 8, 10; Step 3 weeks 0, 2, 4, 6, 8, 10, 12
Immune activation markers in CSF
Immune activation markers in CSF
Measured: Step 1 week 0, 6; Step 2 week 0; Step 3 week 0, 12
Extent of cerebral inflammation in MR Spectroscopy (MRS)
Extent of cerebral inflammation in MR Spectroscopy (MRS)
Measured: Step 1 week 0, 6; Step 2 week 0; Step 3 week 0, 12
Viral load area under the curve (AUCv)
Viral load area under the curve (AUCv)
Measured: during the 4 weeks after viral rebound
Responses to pilot discrete choice experiment survey
Describe participant preferences about participation in HIV remission trials with treatment interruptions
Measured: Step2 wk0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Mar 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Sandhya C Vasan, MD PhD, Study chair, Henry M. Jackson Foundation for the Advancement of Military Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505501
- Sponsor's protocol ID
- RV550
- Status last verified
- Apr 2025
- First submitted
- 13 Jul 2020
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Individuals With Acute HIV Infection
- ClinicalTrials.gov ID
- NCT04505501
- Acronym / sponsor ID
- RV550
- Conditions
- HIV/AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine, Walter Reed Army Institute of Research (WRAIR)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Aug 2020 (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.
Reducing HIV persistence in lymph nodes by Interleukin-15 (IL-15) Receptor super-agonist (N-803) in Individuals with Acute HIV Infection
Detailed description
This is a phase II, randomized, unblinded, controlled trial to investigate the safety, tolerability and immunomodulation effect of combining N-803 with ART during AHI. The study will be conducted at the Thai Red Cross AIDS Research Centre (TRCARC)/King Chulalongkorn Memorial Hospital and the Faculty of Medicine, Chulalongkorn University in Bangkok, Thailand.
Eligible participants will be asked to undergo LN Bx at baseline (untreated AHI), prior to initiating dolutegravir-based ART.
This study will have three steps.
In Step 1, N-803 will be administered subcutaneously at weeks 0, 3, 6 (total 3 doses) and will be initiated together with ART. Participants will be asked to undergo a second inguinal LN Bx on the opposite groin approximately at week 6 (no later than 1 week after completion of study agents). They will be followed for safety parameters at weeks 8 and 12, after which they will roll over to the RV412, WRAIR#2178 safety monitoring protocol. Step 1 duration for individual participants will be approximately 12 weeks. Step 1 has been completed as per protocol by 12 participants, 8 N-803 recipients and 4 ART only participants and study recruitment has ended.
In Step 2, participants who have completed Step 1 as per protocol and remain virologically controlled will be given a single dose of N-803 followed by ATI. The N-803 dose will be offered to all these participants regardless of initial randomization in Step 1. In Step 2, N-803 will be administered at Step 2 week 0 followed by ATI on the same day. The participants will be followed during ATI for viral rebound and monitored for the restart criteria for a maximum of 12 weeks. Participants who do not meet ART restart criteria at the end of Step 2 will proceed to RV412, WRAIR#2178 for safety follow-up.
In Step 3, participants who did restart ART during Step 2 will be monitored for safety after restarting ART. Participants will be monitored every 2 weeks for a total of 12 weeks in Step 3. Any participants who may not have achieved HIV suppression by the end of Step 3 and the study will also proceed to RV412, WRAIR#2178 for continuing safety follow-up. Total study duration through data analysis and closure is estimated at five years.
It is hypothesized that N-803 initiated with ART during AHI, will be safe, and will lead to a reduction of HIV reservoir size in LN, demonstrated by decreased frequencies of vRNA+ and vDNA+ cells in the LNs, in comparison with ART alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-803 | Experimental | Drug: N-803Step 1: N-803 at 6mcg/kg every 3 weeks for 3 doses plus ART (n=10) Step 2 : N-803 at 6mcg/kg at week 0 single dose (n=8), ATI after N-803 injection until week 12 (If meet criteria to restart ART, participants will go to step 3). Step 3: ART restart (week 0 to week 12). |
| Control | No intervention | –Step 1: ART alone (n=5) Step 2 : N-803 at 6mcg/kg at week 0 single dose (n=8), ATI after N-803 injection until week 12 (If meet criteria to restart ART, participants will go to step 3). Step 3: ART restart (week 0 to week 12). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 years and above.
- Acute HIV infection (Fiebig I to V: Fiebig I: RNA+, p24 antigen-; Fiebig II: p24 antigen+, IgM-; Fiebig III: IgM+, Western Blot-; Fiebig IV: Western Blot indeterminate; Fiebig V: Western Blot+ without p31 protein band)
- All female participants of childbearing potential must have a negative urine pregnancy test at the screening visit
- Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception (as defined in section 8.1.2 Pregnancy Risks) during therapy and for 4 months after completion of therapy
- Can read and write Thai and/or English language and must be able to understand and complete the informed consent process
Key exclusion criteria (20 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
- Receipt of any vaccine within 2 weeks prior to study enrollment and anticipated need for any vaccine within 2 weeks prior to or after any of the study agent administrations.
- Current or anticipated use of systemic steroid medications.
- Any clinically significant acute or chronic medical condition, including, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiac disease, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.)
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 |
|---|---|---|
| N-803Also: ALT-803N-803 is a novel IL-15 superagonist complex that enhances NK cell and CD8+ T-cell proliferation and activation. | Drug | N-803 |
Primary outcome
Rate of occurrence of ≥ grade 3 adverse events determined to be related (Safety)
Time frame: at time of study completion at week 12
Rate of occurrence of ≥ grade 3 adverse events determined to be related
Frequency of vRNA+ and vDNA+ cells and levels of vDNA and vRNA in LNs
Time frame: At baseline (week 0) and week 6
Frequency of vRNA+ and vDNA+ cells and levels of vDNA and vRNA in LNs
Frequency, phenotype and function of CD8+ T cells and innate cells in LNs
Time frame: At baseline (week 0) and week 6
Frequency, phenotype and function of CD8+ T cells and innate cells in LNs
Time (days) from ATI to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL following ATI.
Time frame: viral rebound during Step 2 ATI
Time (days) from ATI to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL following ATI.
9 secondary outcomes
Frequency, phenotype and function of NK, T, B and other immune cells in LNs and blood
Time frame: Step 1 weeks 0, 3, 6, 12; Step 2 weeks 0, 2, 4, 6, 8, 10; Step 3 weeks 0, 2, 4, 6, 8, 10, 12
HIV-specific antibody levels and ADCC, ADCP, ADCVI activities
Time frame: Step 1 weeks 0, 3, 6, 12; Step 2 weeks 0, 2, 4, 6, 8, 10; Step 3 weeks 0, 2, 4, 6, 8, 10, 12
Frequency of cells harboring HIV-1 vDNA, vRNA, intact genome and replication competent HIV-1 in PBMC
Time frame: Step 1 weeks 0, 3, 6, 12; Step 2 week 0; Step 3 week 12
Host and viral genes by transcriptome analysis
Time frame: Step 1 week 0 and 6
Immune activation markers in blood
Time frame: Step 1 weeks 0, 3, 6, 12; Step 2 weeks 0, 2, 4, 6, 8, 10; Step 3 weeks 0, 2, 4, 6, 8, 10, 12
Immune activation markers in CSF
Time frame: Step 1 week 0, 6; Step 2 week 0; Step 3 week 0, 12
Extent of cerebral inflammation in MR Spectroscopy (MRS)
Time frame: Step 1 week 0, 6; Step 2 week 0; Step 3 week 0, 12
Viral load area under the curve (AUCv)
Time frame: during the 4 weeks after viral rebound
Responses to pilot discrete choice experiment survey
Time frame: Step2 wk0
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 13 Apr 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.
Sandhya C Vasan, MD PhD study chair
Henry M. Jackson Foundation for the Advancement of Military Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-803 in people with HIV/AIDS, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
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 19 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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 Thailand. 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?
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?
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?
Rate of occurrence of ≥ grade 3 adverse events determined to be related (Safety) (time frame: at time of study completion at week 12). The study lists 4 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 13 Apr 2025.