AzTrials
AzTrials

HIV InfectionsPhase 4NCT02519777

Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)

A Phase 4 study testing Dolutegravir (DTG) and Maraviroc (MVC) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV] medications) to participants' existing ART regimens improved… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Dolutegravir (DTG) and Maraviroc (MVC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
191 participants
Where
30 sitesin 5 countries
Study dates
21 Apr 2016to 5 Jan 2021
Phase
Phase 4
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

  • HIV-1 infection, documented by:
  • a licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. NOTE: The term "licensed" refers to a United States Food and Drug Administration (FDA)-approved kit, which is required for all IND studies, or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally. Non-US sites are encouraged to use US FDA-approved methods for IND studies. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA. OR
  • Documentation of HIV diagnosis in the medical record by a healthcare provider.
  • On current ART for at least 6 months prior to study entry with no interruption in treatment of greater than or equal to 7 consecutive days. Note: The following ART changes are allowed:
  • Tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide fumarate (TAF)/TAF-containing fixed-dose combination regimens
  • Ritonavir (RTV) to cobicistat (COBI)/COBI-containing fixed-dose combination regimens
Show all 27Show fewer
  • No plans to change ART while on study. Note: The following planned ART changes are allowed:
  • TDF to TAF/TAF-containing fixed-dose combination regimens
  • RTV to COBI/COBI-containing fixed-dose combination regimens
  • HIV-1 plasma RNA less than 50 copies/mL obtained within 90 days prior to study entry by any FDA-approved assay at any United States laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
  • No more than one HIV-1 plasma RNA greater than or equal to 50 and less than 200 copies/mL (only one "blip") in the past 6 months with a subsequent HIV-1 plasma RNA less than 50 copies/mL. NOTE: There should be no plasma HIV-1 RNA greater than 200 copies/mL within the 6 months prior to study entry.
  • HAND diagnosis (ANI, MND, or HAD) within 60 days prior to study entry. HAND is defined as at least mild impairment on neurocognitive testing (more than one standard deviation below appropriate normative data in two domains of functioning) and no severely confounding factors.
  • Screening laboratory values obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs:
  • Absolute neutrophil count (ANC) greater than or equal to 500/mm^3
  • Hemoglobin greater than or equal to 7.5 g/dL
  • Platelet count greater than or equal to 40,000/mm^3
  • Creatinine less than or equal to 2.0 x upper limit of normal (ULN)
  • Aspartate transaminase (AST) less than or equal to 5 x ULN
  • Alanine transaminase (ALT) less than 3 x ULN
  • Alkaline phosphatase less than or equal to 5 x ULN
  • Total bilirubin less than 1.5 x ULN. NOTE: If the potential participant is taking an indinavir (IDV)- or atazanavir (ATV)-containing regimen at the time of screening, total bilirubin less than or equal to 5 x ULN is acceptable.
  • Creatinine clearance (CrCl) greater than or equal to 60 mL/min, either measured or estimated by Cockcroft-Gault equation. NOTE: A calculator for estimating the CrCl can be found at www.fstrf.org/ACTG/ccc.html
  • Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, hysterectomy or bilateral salpingectomy or bilateral oophorectomy or tubal ligation) must have a negative serum or urine pregnancy test by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC) / CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs within 48 hours prior to study entry
  • Females of reproductive potential must agree not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must use at least one reliable form of contraception. Female participants must use contraceptives while receiving study treatment and for 6 weeks after stopping study treatment. More information on this criterion is available in the protocol.
  • Ability and willingness of participant to complete the neuropsychological tests
  • Ability and willingness of participant or a legally authorized representative (see protocol for more information) to provide informed consent
  • Ability and willingness to take oral study medications

Who cannot join

  • Current or past medical condition(s) that in the opinion of the investigator prevents attribution of the cause of cognitive impairment to HIV. For example:
  • Major depressive disorder with psychotic features
  • Traumatic Brain Injury (TBI) with a clear impact on activities of daily living
  • Developmental delay, intellectual deficit, and/or severe educational disability resulting in some dependence for activities of daily living
  • Ongoing substance use disorder with significant impact on activities of daily living. Difficult or impossible to determine whether cognitive or functional decline is due to substance use or HIV, or both
  • Evidence of intoxication or withdrawal during the screening evaluation
Show all 18Show fewer
  • Central nervous system (CNS) infections or opportunistic conditions: brain abscess (bacterial, mycobacterial, fungal or Toxoplasma), meningitis with persistent neurologic impairment, primary CNS lymphoma, progressive multifocal leukoencephalopathy (PML), or another structural brain lesion with neurological sequelae
  • Other CNS conditions: non-opportunistic primary or metastatic brain tumors, uncontrolled seizure disorder, progressive multiple sclerosis, stroke with neurological sequelae, or dementia due to causes other than HIV (eg, Alzheimer's disease)
  • Constitutional illness (eg, persistent unexplained fever, diarrhea, significant weight loss, disabling weakness) within 30 days of screening
  • Known untreated B12 deficiency or malnutrition (body mass index [BMI] less than 18) at screening
  • Evidence of current hepatitis C virus infection (HCV) (ie, HCV antibody [Ab] positive within 90 days prior to study entry unless also shown to be plasma HCV RNA negative within the same time period)
  • Unstable and advanced liver disease (as defined by the presence of at least one of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice)
  • Prior or current use of any CCR5 antagonist (such as MVC and cenicriviroc [CVC]) and integrase inhibitor (such as RAL, DTG, and elvitegravir [EVG])
  • Current use of any medication, including antiretrovirals, prohibited in the study (refer to the A5324 protocol-specific web page [PSWP] for the prohibited medications)
  • Breastfeeding
  • Presence of an AIDS-defining opportunistic infection within 6 months prior to entry. Note: Refer to the A5324 Manual of Operations (MOPS) for the list of AIDS-defining opportunistic infections.
  • Active syphilis or treatment for syphilis within 90 days prior to study entry. NOTE: Active syphilis is defined as four-fold increase in serum rapid plasma reagin (RPR) or venereal disease research laboratory (VDRL) tests in an individual with past syphilis, or newly reactive serum RPR or VDRL with a reactive confirmatory test (enzyme immunoassays [EIA] or chemiluminescent assay [CIA], T. pallidum particle agglutination [TP-PA], or fluorescent treponemal antibody absorbed [FTA-ABS]).
  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation

Trial locations and contacts

30 sites in 5 countries.

30 sites in 5 countries

United States23 sites

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Cincinnati Clinical Research Site

    Cincinnati, Ohio, 45219

  • Case Clinical Research Site

    Cleveland, Ohio, 44106

  • Ohio State University CRS

    Columbus, Ohio, 43210

  • Trinity Health and Wellness Center CRS

    Dallas, Texas, 75208

  • Greensboro CRS

    Greensboro, North Carolina, 27401

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Vanderbilt Therapeutics (VT) CRS

    Nashville, Tennessee, 37204

  • Weill Cornell Chelsea CRS

    New York, New York, 10010

  • Weill Cornell Uptown CRS

    New York, New York, 10065

  • New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • Penn Therapeutics, CRS

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hospital Clinical Research Site (TMH CRS) CRS

    Providence, Rhode Island, 02906

  • University of Rochester Adult HIV Therapeutic Strategies Network CRS

    Rochester, New York, 14642

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

  • University of Washington AIDS CRS

    Seattle, Washington, 98104-9929

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010

  • Harbor-UCLA CRS

    Torrance, California, 90502

  • Whitman-Walker Health CRS

    Washington D.C., District of Columbia, 20005

Other trials in United States

South Africa3 sites

  • Durban International Clinical Research Site CRS

    Durban, KwaZulu-Natal, 4052

  • Wits Helen Joseph Hospital CRS (Wits HJH CRS)

    Johannesburg, Gauteng, 2092

  • Famcru Crs

    Tygerberg, Western Cape, 7505

Other trials in South Africa

Thailand2 sites

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS

    Bangkok, 10330

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

    Chiang Mai, 50200

Other trials in Thailand

Brazil1 site

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, 21040-360

Other trials in Brazil

Puerto Rico1 site

  • Puerto Rico AIDS Clinical Trials Unit CRS

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV

People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV] medications) to participants' existing ART regimens improved participants' neurocognitive performance.

Read the detailed description

HIV-infected people often have cognitive dysfunction (HIV-associated neurocognitive disorder, or HAND), which includes asymptomatic neurocognitive impairment (ANI), mild neurocognitive disorder (MND), and HIV-associated dementia (HAD), even if they are on ART and have undetectable viral loads. In this study, researchers evaluated the effectiveness of adding MVC and DTG to the current ART regimen of HIV-infected people with undetectable (<50 copies/mL) plasma HIV-1 RNA who had neurocognitive impairment and who had been on stable ART for at least 6 months prior to study entry. The purpose of this study was to evaluate if the addition of MVC and DTG to participants' existing ART regimens improved participants' neurocognitive performance.

Participants were randomly assigned to one of three arms. All participants remained on their existing ART regimens; they took their assigned study drugs in addition to their ART regimen. Study visits occurred at entry and Weeks 2, 4, 12, 24, 48, 72, and 96. Visits may have included physical examinations, blood collection, neurocognitive testing, pregnancy testing, and questionnaires. Some participants may have had an optional lumbar puncture procedure at study entry and Week 48. Participants returned for refills of study drugs on Weeks 36, 60, and 84.

Conditions
HIV Infections
Being tested
Placebo for maraviroc (MVC), Placebo for dolutegravir (DTG), Dolutegravir (DTG), Maraviroc (MVC)
Keywords
HIV-Associated Neurocognitive Disorder
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo for maraviroc (MVC)Drug

    Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen

  • Placebo for dolutegravir (DTG)Drug

    Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen

  • Dolutegravir (DTG)Drug

    Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen

  • Maraviroc (MVC)Drug

    Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen

Study groups in NCT02519777
Study groupRoleWhat they receive
Arm A: Placebo MVC and placebo DTGPlacebo comparatorIn addition to their existing ART regimens, participants in Arm A received placebo for MVC and placebo for DTG.
Receives: Drug: Placebo for maraviroc (MVC); Drug: Placebo for dolutegravir (DTG)
Arm B: DTG and placebo MVCExperimentalIn addition to their existing ART regimens, participants in Arm B received DTG and placebo for MVC.
Receives: Drug: Placebo for maraviroc (MVC); Drug: Dolutegravir (DTG)
Arm C: MVC and DTGExperimentalIn addition to their existing ART regimens, participants in Arm C received MVC and DTG
Receives: Drug: Dolutegravir (DTG); Drug: Maraviroc (MVC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline

    The normalized composite neurocognitive test score (total z-score) was defined as the average of the z-scores from the following tests:

    Domestic (US-based) and International Participants:

    • Grooved pegboard dominant
    • Grooved pegboard non-dominant
    • Hopkins Verbal Learning Test (HVLT-R) Learning trials
    • HVLT-R Delayed recall
    • HVLT-R Delayed recognition
    • Semantic verbal fluency

    Domestic only:

    • Stroop color naming
    • Stroop word reading
    • Stroop interference trial
    • Letter fluency
    • Trail Making A
    • Trail Making B
    • WAIS-III Symbol search
    • Digit Symbol

    International only:

    • Timed Gait
    • Finger Tapping Dominant
    • Finger Tapping Non-dominant
    • Color Trail 1

    Z-scores were calculated using a demographically appropriate norming process. Higher z-scores correspond with better neurocognitive performance. Change was calculated as the total z-score at Week 48 minus the total z-score at Baseline.

    Measured: Measured at Baseline and Week 48

Secondary outcomes (16)

  1. Number of Participants With Treatment Related Adverse Events (AEs)

    Treatment Related Adverse Events were determined by the study sites indicating a relationship between an adverse event and the study treatment.

    Measured: Measured from treatment initiation through Week 96

  2. Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline

    The normalized composite neurocognitive test score (total z-score) was defined as the average of the z-scores from the following tests:

    Domestic and International Participants:

    • Grooved pegboard dominant
    • Grooved pegboard non-dominant
    • HVLT-R Learning trials
    • HVLT-R Delayed recall
    • HVLT-R Delayed recognition
    • Semantic verbal fluency

    Domestic only:

    • Stroop color naming
    • Stroop word reading
    • Stroop interference trial
    • Letter fluency
    • Trail Making A
    • Trail Making B
    • WAIS-III Symbol search
    • Digit Symbol

    International only:

    • Timed Gait
    • Finger Tapping Dominant
    • Finger Tapping Non-dominant
    • Color Trail 1
    • Color Trail 2

    Z-scores were calculated using a demographically appropriate norming process. Higher z-scores correspond with better neurocognitive performance. Change was calculated as the total z-score at the given time point minus the total z-score at Baseline.

    Measured: Measured at Baseline and Weeks 24, 72, and 96

  3. Change in Functional Status Scores

    Functional status scores were calculated based on the instrumental activities of daily living (IADLs) forms. IADL scores were calculated as the sum of the eight IADL tasks where the task scores were equal to 1 if a participant did not need assistance with the task and equal to 0 if a participant needed some level of help with the task. The maximum possible functional status score was 8, while the minimum possible functional status score was 0, with higher functional status scores indicating a higher level of functionality.

    Measured: Measured at Baseline and Weeks 24, 48, 72, and 96

  4. Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL

    The number of participants with Plasma HIV-1 RNA greater than or equal to 50 copies/mL was assessed at each given time point.

    Measured: Measured at Weeks 24, 48, and 96

  5. CD4+ T-cell Counts

    CD4+ T-cell counts were recorded at the given time point

    Measured: Measured at Weeks 24, 48, and 96

  6. Change in CD4+ T-cell Count

    Changes in CD4+ T-cell count were calculated as the CD4+ T-cell count at a given time point minus the CD4+ T-cell count at Baseline.

    Measured: Measured at Baseline and Weeks 24, 48, and 96

  7. CD8+ T-cell Counts

    CD8+ T-cell counts were recorded at the given time point

    Measured: Measured at Weeks 24, 48, and 96

  8. Change in CD8+ T-cell Count

    Changes in CD8+ T-cell count were calculated as the CD8+ T-cell count at a given time point minus the CD8+ T-cell count at baseline.

    Measured: Measured at Baseline and Weeks 24, 48, and 96

  9. Change in Log10 sCD14 in Plasma at Week 48 From Baseline

    Changes in Log10 sCD14 in Plasma were calculated as the Log10 sCD14 in Plasma at Week 48 minus the Log10 sCD14 in Plasma at Baseline.

    Measured: Measured at Baseline and Week 48

  10. Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline

    Changes in Log10 MIP-1 Beta in Plasma were calculated as the Log10 MIP-1 Beta in Plasma at Week 48 minus the Log10 MIP-1 Beta in Plasma at Baseline. Results below the lower limit of quantification were set to the lower limit value of 11.

    Measured: Measured at Baseline and Week 48

  11. Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline

    Changes in Log10 sTNFr-II in Plasma were calculated as the Log10 sTNFr-II in Plasma at Week 48 minus the Log10 sTNFr-II in Plasma at Baseline.

    Measured: Measured at Baseline and Week 48

  12. Change in Log10 VCAM in Plasma at Week 48 From Baseline

    Changes in Log10 VCAM in Plasma were calculated as the Log10 VCAM in Plasma at Week 48 minus the Log10 VCAM in Plasma at Baseline.

    Measured: Measured at Baseline and Week 48

  13. Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline

    Changes in Log10 MIP-1 Beta in CSF were calculated as the Log10 MIP-1 Beta in CSF at Week 48 minus the Log10 MIP-1 Beta in CSF at Baseline.

    Measured: Measured at Baseline and Week 48

  14. Change in Log10 IP-10 in CSF at Week 48 From Baseline

    Changes in Log10 IP-10 in CSF were calculated as the Log10 IP-10 in CSF at Week 48 minus the Log10 IP-10 in CSF at Baseline.

    Measured: Measured at Baseline and Week 48

  15. Change in Log10 Neopterin in CSF at Week 48 From Baseline

    Changes in Log10 Neopterin in CSF were calculated as the Log10 Neopterin in CSF at Week 48 minus the Log10 Neopterin in CSF at Baseline.

    Measured: Measured at Baseline and Week 48

  16. Change in Log10 NFL in CSF at Week 48 From Baseline

    Changes in Log10 NFL in CSF were calculated as the Log10 NFL in CSF at Week 48 minus the Log10 NFL in CSF at Baseline.

    Measured: Measured at Baseline and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2015 (estimated)
  2. Study start21 Apr 2016
  3. Primary completion2 Dec 2019
  4. Study completion5 Jan 2021

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02519777
Sponsor's protocol ID
A5324
Other IDs
11909
Status last verified
Apr 2022
First submitted
6 Aug 2015
Last updated
22 Apr 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dolutegravir (DTG) and Maraviroc (MVC) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in 5 countries.

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 27 inclusion and 18 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, South Africa, Thailand, Brazil, Puerto Rico. 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 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?

Yes. Results are posted in the registry (first posted 2 Mar 2022). 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?

Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline (time frame: Measured at Baseline and Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02519777.

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 22 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in