Effect of High Dose Vitamin D Supplementation on HIV Latency

Summary

HIV persists despite antiretroviral therapy (ART) and is associated with chronic inflammation. This inflammation is thought to prevent an effective immune response against the virus and is mediated at least in part by gut epithelial permeability and microbial translocation. HIV accumulates preferentially within Th17 cells with time on ART; these memory CD4+ T cells are highly susceptible to HIV infection and are concentrated within the gut. Vitamin D promotes gut epithelial integrity in animal models and exerts anti-inflammatory effects on the human immune system including down-modulation of Th17 cell frequency. This study will evaluate whether high dose vitamin D is able to reduce immune activation and Th17 cell frequency, to improve gut barrier integrity and the gut microbiome and reduce HIV persistence in participants on long-term suppressive ART.

Conditions

• Human Immunodeficiency Virus

Interventions

DRUG

Vitamin D3, 10000 Intl Units Oral Capsule

Vitamin D capsule. Over-encapsulated to mimic placebo oral capsule. Eligible study participants will be randomized 1:1 to vitamin D or placebo one capsule daily from week 0 to week 24. All participants will be advised to achieve 1 gram daily dietary calcium intake whilst on study. Blood and urine will be taken at 0, 12, 24 and 36 weeks to evaluate the primary and secondary endpoints. Rectal swabs will be taken at 0, 24 and 36 weeks. All participants will continue antiretroviral therapy throughout the study.

DRUG

Placebo oral capsule

Capsule containing oleic acid. Over-encapsulated to mimic vitamin D3 capsule. Eligible study participants will be randomized 1:1 to vitamin D or placebo one capsule daily from week 0 to week 24. All participants will be advised to achieve 1 gram daily dietary calcium intake whilst on study. Blood and urine will be taken at 0, 12, 24 and 36 weeks to evaluate the primary and secondary endpoints. Rectal swabs will be taken at 0, 24 and 36 weeks. All participants will continue antiretroviral therapy throughout the study.

Sponsors & Collaborators

• Melbourne Health

  collaborator OTHER

• The Alfred

  collaborator OTHER

• Melbourne Sexual Health Centre

  collaborator UNKNOWN

• University of Illinois at Chicago

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Melbourne

  lead OTHER

Principal Investigators

• Sharon Lewin, FRACP PhD · The Peter Doherty Institute for Infection and Immunity, University of Melbourne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-29

Primary Completion

2019-05-21

Completion

2019-05-21

Countries

• Australia

Study Locations