NCT03753867

RA Effect on Cell Surface Molecules in Vivo

Retinoic Acid Effect on Cell Surface Molecules in Vivo

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-07
• Primary completion: 2019-05-08
• Completion: 2019-05-08
• First posted: 2018-11-27
• Last updated: 2020-03-04