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RA Effect on Cell Surface Molecules in Vivo

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ClinicalTrials.gov Identifier: NCT03753867
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Acitretin Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retinoic Acid Effect on Cell Surface Molecules in Vivo
Estimated Study Start Date : January 7, 2019
Estimated Primary Completion Date : May 8, 2019
Estimated Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Acitretin

Arm Intervention/treatment
Experimental: Acitretin treatment Drug: Acitretin
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 Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 5 months ]
    Safety of Acitretin use in healthy volunteers will be assessed using safety labs and C-SSRS


Secondary Outcome Measures :
  1. Change in α4β7 expression on peripherally circulating CD4 T cells [ Time Frame: Serial phlebotomy measured over 5 months ]
    Absolute change in α4β7 expression on peripherally circulating CD4 T cells measured using flow cytometry

  2. Maximum Plasma Concentration [Cmax] [ Time Frame: Trough concentrations measured serially over 2 months of active treatment ]
    Serum concentrations measured by HPLC

  3. Change in RIG-1 expression, p300 expression, mTOR expression [ Time Frame: Serial phlebotomy measured over 5 months ]
    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

  4. Area Under the Curve [AUC]). [ Time Frame: Trough concentrations measured serially over 2 months of active treatment ]
    Serum concentrations measured by HPLC



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753867


Contacts
Contact: Jonathan B Angel, MD, FRCPC 613-737-8899 ext 72406 jangel@toh.ca
Contact: Michaeline McGuinty, MD 289-668-3798 mimcguinty@toh.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Jonathan B Angel, MD, FRCPC Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03753867     History of Changes
Other Study ID Numbers: 2018 0639
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Acitretin
Keratolytic Agents
Dermatologic Agents