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RA Effect on Cell Surface Molecules in Vivo

Primary Purpose

HIV Infections

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Acitretin
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male gender
  2. Age 18 - 65
  3. Able to provide informed consent
  4. Willingness to participate in study treatment and follow-up
  5. Willingness for serial phlebotomy and storage and future viro-immunological assays

Exclusion Criteria:

  1. Female gender
  2. Participants with a known hypersensitivity/allergy to the acitretin.
  3. Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.
  4. Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis
  5. Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction
  6. Previous or current history of mood disorder, psychosis, or suicidality
  7. Participants currently receiving ongoing treatment with methotrexate, tetracyclines, or other retinoids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Acitretin treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Safety of Acitretin use in healthy volunteers will be assessed using safety labs and C-SSRS

    Secondary Outcome Measures

    Change in α4β7 expression on peripherally circulating CD4 T cells
    Absolute change in α4β7 expression on peripherally circulating CD4 T cells measured using flow cytometry
    Maximum Plasma Concentration [Cmax]
    Serum concentrations measured by HPLC
    Change in RIG-1 expression, p300 expression, mTOR expression
    Absolute change in RIG-1 expression by qRTPCR, and change in p300 expression by western blot, change in mTOR expression by qRTPCR and mTOR total/phosphorylated by western blot
    Area Under the Curve [AUC]).
    Serum concentrations measured by HPLC

    Full Information

    First Posted
    October 1, 2018
    Last Updated
    March 2, 2020
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03753867
    Brief Title
    RA Effect on Cell Surface Molecules in Vivo
    Official Title
    Retinoic Acid Effect on Cell Surface Molecules in Vivo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was withdrawn.
    Study Start Date
    January 7, 2019 (Anticipated)
    Primary Completion Date
    May 8, 2019 (Anticipated)
    Study Completion Date
    May 8, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells
    Detailed Description
    Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acitretin treatment
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Acitretin
    Intervention Description
    Acitretin will be provided to participants in the formulation Soriatane. Soriatane doses are oral tablets taken daily by the participant. Participants will then receive 35mg of oral acitretin (Soriatane) daily for 8 weeks during the intervention phase. Participants will be asked to return two months after completion of the acitretin course for clinical follow-up and additional phlebotomy for laboratory testing.
    Primary Outcome Measure Information:
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Description
    Safety of Acitretin use in healthy volunteers will be assessed using safety labs and C-SSRS
    Time Frame
    up to 5 months
    Secondary Outcome Measure Information:
    Title
    Change in α4β7 expression on peripherally circulating CD4 T cells
    Description
    Absolute change in α4β7 expression on peripherally circulating CD4 T cells measured using flow cytometry
    Time Frame
    Serial phlebotomy measured over 5 months
    Title
    Maximum Plasma Concentration [Cmax]
    Description
    Serum concentrations measured by HPLC
    Time Frame
    Trough concentrations measured serially over 2 months of active treatment
    Title
    Change in RIG-1 expression, p300 expression, mTOR expression
    Description
    Absolute change in RIG-1 expression by qRTPCR, and change in p300 expression by western blot, change in mTOR expression by qRTPCR and mTOR total/phosphorylated by western blot
    Time Frame
    Serial phlebotomy measured over 5 months
    Title
    Area Under the Curve [AUC]).
    Description
    Serum concentrations measured by HPLC
    Time Frame
    Trough concentrations measured serially over 2 months of active treatment

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male gender Age 18 - 65 Able to provide informed consent Willingness to participate in study treatment and follow-up Willingness for serial phlebotomy and storage and future viro-immunological assays Exclusion Criteria: Female gender Participants with a known hypersensitivity/allergy to the acitretin. Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year. Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction Previous or current history of mood disorder, psychosis, or suicidality Participants currently receiving ongoing treatment with methotrexate, tetracyclines, or other retinoids
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan B Angel, MD, FRCPC
    Organizational Affiliation
    Ottawa Hospital Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    RA Effect on Cell Surface Molecules in Vivo

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