Effect of High Dose Vitamin D Supplementation on HIV Latency

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 29, 2018

Primary Completion Date

May 21, 2019

Study Completion Date

May 21, 2019

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."

Trial Locations (4)

3000

The Peter Doherty Institute for Infection and Immunity, Melbourne

3004

The Alfred Hospital - Department of Infectious Diseases, Melbourne

3050

Royal Melbourne Hospital, Melbourne

3053

Melbourne Sexual Health Centre, Melbourne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Melbourne Health

OTHER

collaborator

The Alfred

OTHER

collaborator

Melbourne Sexual Health Centre

UNKNOWN

collaborator

University of Illinois at Chicago

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of Melbourne

OTHER

NCT03426592 - Effect of High Dose Vitamin D Supplementation on HIV Latency | Biotech Hunter | Biotech Hunter