RA Effect on Cell Surface Molecules in Vivo

NCT03753867 | Withdrawn Phase 1 DMC

• 1 other identifier: 2018 0639
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

  up to 5 months

Secondary Outcomes (4)

• Change in α4β7 expression on peripherally circulating CD4 T cells

  Serial phlebotomy measured over 5 months

• Maximum Plasma Concentration [Cmax]

  Trough concentrations measured serially over 2 months of active treatment

• Change in RIG-1 expression, p300 expression, mTOR expression

  Serial phlebotomy measured over 5 months

• Area Under the Curve [AUC]).

  Trough concentrations measured serially over 2 months of active treatment

Study Arms (1)

Acitretin treatment

EXPERIMENTAL

Drug: Acitretin

Interventions

Acitretin DRUG

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.

Acitretin treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Jonathan B Angel, MD, FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: November 27, 2018
• Study Start: January 7, 2019
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03