RA Effect on Cell Surface Molecules in Vivo

NCT ID: NCT03753867

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-05-08

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acitretin treatment

Group Type: EXPERIMENTAL

Acitretin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan B Angel, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Other Identifiers

2018 0639

Identifier Type: -

Identifier Source: org_study_id