AzTrials
AzTrials

HIV-1 InfectionPhase 1/2NCT02440789

Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)

A Phase 1/2 study testing Sirolimus in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 10 sites in United States.

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

The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes the level of HIV in the participants'… 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?
Sirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
10 sitesUnited States
Study dates
21 Dec 2015to 1 Feb 2018
Phase
Phase 1/2
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
  • On continuous ART for ≥24 months prior to study entry.
  • CD4+ cell count ≥350 cells/mm^3
  • Plasma HIV-1 RNA below the level of quantification for ≥24 months.
  • White blood cell (WBC) ≥3000/mm^3
  • Platelet count ≥125,000/mm^3
Show all 13Show fewer
  • Absolute neutrophil count (ANC) >1300/mm^3
  • Aspartate aminotransferase (AST) <1.25 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) <1.25 x ULN
  • Calculated creatinine clearance (CrCl) ≥60 mL/min
  • Fasting or non-fasting triglyceride level ≤350 mg/dL
  • Fasting or non-fasting LDL <160 mg/dL
  • Urine protein to urine creatinine ratio ≤1 g/g from random urine collection

Who cannot join

  • Serious illness requiring systemic treatment and/or hospitalization
  • Documentation of any CDC Category C AIDS-indicator condition or oropharyngeal candidiasis (thrush)
  • Intended modification of ART during the study.
  • Latent tuberculosis (TB) infection
  • TB disease within 48 weeks prior to study entry requiring treatment.
  • History of active hepatitis B (HBV) infection.
Show all 17Show fewer
  • Hepatitis C virus (HCV) RNA-positive
  • Previous myelodysplasia syndrome, lymphoproliferative disease, lung disease, malignancies, congestive heart failure, life-threatening fungal infection or herpes-zoster/varicella-zoster viral infection requiring treatment.
  • Detectable Epstein-Barr virus (EBV) in blood
  • Active infection other than HIV that required receipt of systemic antibiotic therapy by intravenous infusion
  • History of major hypersensitivity reaction to macrolide drugs including angioedema, anaphylaxis, drug-induced dermatitis, or hypersensitivity vasculitis.
  • Currently pregnant or breastfeeding, or planning to become pregnant prior to or during the study.
  • Use of immunomodulators (eg, interleukins, interferons, and cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy.
  • Active drug or alcohol use or dependence
  • Vaccination within 14 days prior to study entry.
  • On or planned to change to a PI-based ART or cobicistat-boosted regimen
  • Anti-human papillomavirus (HPV) therapies

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • The Ponce de Leon Center CRS (5802)

    Atlanta, Georgia, 30308

  • Univ. of Cincinnati CRS (2401)

    Cincinnati, Ohio, 45267

  • Houston AIDS Research Team CRS (31473)

    Houston, Texas, 77030

  • Univ. of Miami AIDS CRS (901)

    Miami, Florida, 33136

  • Weill Cornell Uptown CRS (7803)

    New York, New York, 10011

  • 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS

    Rochester, New York, 14642

  • 801 University of California, San Francisco HIV/AIDS CRS

    San Francisco, California, 94110

  • University of Washington AIDS CRS (1401)

    Seattle, Washington, 98104

  • Washington University CRS (2101)

    St Louis, Missouri, 63110

  • Whitman Walker Health CRS (31791)

    Washington D.C., District of Columbia, 20005

Other trials in United States

About this study

Official title: Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy

The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes the level of HIV in the participants' blood; and how sirolimus interacts with ART in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus had also been used for the prevention of complications after stem cell transplants and as a treatment for certain kinds of cancers in HIV-infected patients.

Read the detailed description

The study was conducted with an initial lead-in period of 12 weeks where participants remained on ART, without study intervention. Samples were collected to define the pre-intervention steady-state of HIV, inflammation and immune activation parameters.

At week 12, sirolimus therapy was initiated for the planned 20 weeks of treatment. In order to achieve therapeutic levels, sirolimus therapy was initiated with lead-in dose of 0.025 or 0.05 mg/kg/day, depending on the ART regimen. Doses for each participant were then adjusted, based on trough blood sirolimus concentrations, to achieve target concentrations between 5 and 10 ng/mL. There were frequent initial visits for sirolimus trough concentration monitoring and potential dose adjustments, at weeks 12.5, 13, 13.5, 14, 14.5, 15, 15.5 and 16. Then visits occurred at weeks 18, 20, 24, 28 and 32. After the week 32 visit, the planned end of study treatment, there was an additional 12 weeks of post-sirolimus follow-up, with a final visit at week 44.

Study visits included physical examinations, clinical assessments, safety monitoring, and blood and oral swab collection. Anal swabs were collected at week 12 and 32. Samples were stored for subsequent protocol testing for the study outcomes.

In the primary analysis, the significance level was 0.05 for all analyses.

Conditions
HIV-1 Infection
Being tested
Sirolimus

What participants receive

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

  • SirolimusDrug

    Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.

    Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.

Study groups in NCT02440789
Study groupRoleWhat they receive
SirolimusExperimentalNot described
Receives: Drug: Sirolimus

What is being measured

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

  1. Number of Participants Who Met the Study-defined Composite Safety Endpoint

    The study-defined primary safety endpoint was a composite endpoint. A participant was considered to have met the endpoint if the participant 1) experienced a new Grade ≥3 Adverse Event (AE), including signs/symptoms, lab toxicity or clinical event, that was definitely, probably or possibly related to study treatment, as judged by the core team, or 2) had a change in CD4+ cell count ( confirmed >50% decline or to <300 cells/mm3) while on sirolimus. The screening visit occurred within 60 days of study entry.

    Measured: Screening to study week 32 (week 20 of Sirolimus)

  2. Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma

    Frequency of HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  3. Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma

    Change in HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  4. Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA

    CD4+ T-cell-associated HIV-1 RNA. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  5. Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA

    Change in CD4+ T-cell-associated HIV-1 RNA (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  6. Efficacy - Virologic: Plasma HIV-1 RNA by SCA

    Plasma HIV-1 RNA by SCA

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  7. Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA

    Change in plasma HIV-1 RNA by SCA (week 32 measurement minus baseline measurement).

    Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Secondary outcomes (39)

  1. Measurement of CD4+ T-cell Counts

    CD4+ T-cell counts. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  2. Change in CD4+ T-cell Counts

    Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  3. Measurement of HIV-1 RNA Levels

    HIV-1 RNA levels by conventional assay

    Measured: weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44

  4. Cell-associated HIV-1 DNA Levels in Total CD4+ Cells

    HIV-1 DNA levels in CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  5. Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells

    Change in HIV-1 DNA levels in CD4+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  6. Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses

    Frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  7. Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  8. Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses

    Frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  9. Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  10. Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses

    Frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  11. Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  12. Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses

    Frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  13. Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  14. Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses

    Frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  15. Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  16. Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses

    Frequency of HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  17. Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses

    Change in HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  18. Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses

    Frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  19. Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  20. Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses

    Frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  21. Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells (week 32 measurement minus baseline measurement).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  22. Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses

    Frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  23. Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  24. Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses

    Frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  25. Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells (week 32 measurement minus baseline measurement).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  26. Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses

    Frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  27. Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses

    Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells (week 32 measurement minus baseline measurement).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  28. Measurement of %CD69+ CD4+ T-cells

    Measurement of %CD69+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  29. Change in of %CD69+ CD4+ T-cells

    Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  30. Measurement of %CD69+ CD8+ T-cells

    Measurement of %CD69+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  31. Change in of %CD69+ CD8+ T-cells

    Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  32. Measurement of %Ki67+ CD4+ T-cells

    Measurement of %Ki67+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  33. Change in of %Ki67+ CD4+ T-cells

    Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement).

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  34. Measurement of %Ki67+ CD8+ T-cells

    Measurement of %Ki67+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  35. Change in of %Ki67+ CD8+ T-cells

    Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  36. Measurement of %PD1+ CD4+ T-cells

    Measurement of %PD1+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  37. Change in of %PD1+ CD4+ T-cells

    Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

  38. Measurement of %PD1+ CD8+ T-cells

    Measurement of %PD1+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).

    Measured: At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44

  39. Change in of %PD1+ CD8+ T-cells

    Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement)

    Measured: At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Timeline

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

  1. First posted12 May 2015 (estimated)
  2. Study start21 Dec 2015
  3. Primary completion2 Nov 2017
  4. Study completion1 Feb 2018

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440789
Sponsor's protocol ID
ACTG A5337
Other IDs
2UM1AI068636
Status last verified
Dec 2019
First submitted
6 Apr 2015
Last updated
3 Aug 2021
Data monitoring committee
Yes

Publications

  • Henrich TJ, Bosch RJ, Godfrey C, Mar H, Nair A, Keefer M, Fichtenbaum C, Moisi D, Clagett B, Buck AM, Deitchman AN, Aweeka F, Li JZ, Kuritzkes DR, Lederman MM, Hsue PY, Deeks SG; ACTG A5337 Team. Sirolimus reduces T cell cycling, immune checkpoint marker expression, and HIV-1 DNA in people with HIV. Cell Rep Med. 2024 Oct 15;5(10):101745. doi: 10.1016/j.xcrm.2024.101745. Epub 2024 Sep 24.

    PubMed 39321793

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sirolimus in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 10 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 13 inclusion and 17 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 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.

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?

Yes. Results are posted in the registry (first posted 30 Dec 2019). 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?

Number of Participants Who Met the Study-defined Composite Safety Endpoint (time frame: Screening to study week 32 (week 20 of Sirolimus)). The study lists 7 primary outcomes in all. 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 NCT02440789, which also lists 1 linked publication.

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 3 Aug 2021.

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