Human Immunodeficiency VirusPhase 2VIVANCT03426592
Effect of High Dose Vitamin D Supplementation on HIV Latency
A Phase 2 study testing Vitamin D3, 10000 Intl Units Oral Capsule in people with Human Immunodeficiency Virus, run by University of Melbourne at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Vitamin D3, 10000 Intl Units Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesAustralia
- Study dates
- 29 Jan 2018to 21 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained
- At least 18 years of age
- Documented HIV-1 infection
- Receiving combination antiretroviral therapy continuously for at least 3 years
- Viral load suppressed below 40 copies/mL, or below assay limit of quantification where limit of quantification is above 40 copies/mL, for at least 3 years (excluding single episodes of HIV viral load 40-500 copies/mL where subsequent viral load was below 40 copies/mL or below assay limit of quantification where limit of quantification is above 40 copies/mL)
- Viral load < 40 copies/ml at screening
Show all 9Show fewer
- Screening 25-hydroxyvitamin D level within 12 months prior to recruitment between 50nM and 125nM
- Agreement not to take any vitamin D containing compounds other than study drug between screening and conclusion of the study
- Agreement not to have vitamin D level checked by a treating doctor during the study unless medically required
Who cannot join
- Any planned change to ART regimen within next 12 months (other than switching tenofovir disoproxil fumarate to tenofovir alafenamide)
- Known current acute or chronic hepatitis B, known current acute or chronic hepatitis C or positive HBsAg or HCV PCR in blood at screening
- Completion of curative treatment for HCV within 6 months prior to screening
- HIV-2 infection
- Any vitamin D supplementation from 6 months prior to the screening 25(OH) vitamin D test until study commencement (including multivitamins containing vitamin D and cod liver oil)
- Any medical indication for vitamin D supplementation, eg osteoporosis, renal impairment (estimated glomerular filtration rate < 60ml/minute), liver cirrhosis
Show all 22Show fewer
- Chronic diarrhoea or fat malabsorption
- Body mass index (BMI >= 35)
- Current hypercalcaemia (corrected calcium greater than 2.60mM), current primary hyperparathyroidism or any history of nephrolithiasis
- Current hyperthyroidism
- History of sarcoidosis or active tuberculosis
- Grade 3 or 4 abnormalities in screening pathology laboratory tests not already excluded by the above criteria at the discretion of the Principal Investigator
- Hypersensitivity to vitamin D preparations
- Concurrent medication with adverse interactions with vitamin D (eg oral glucocorticoids, phenytoin, carbamazepine, barbiturates, rifampicin, rifabutin, St John's wort, thiazide diuretics, digoxin, ketoconazole, itraconazole, nefazodone, isoniazid, cholestyramine, aluminium hydroxide, aripiprazole, danazol, orlistat, perhexiline or sucralfate use) or possible such use within next 12 months
- Current interferon, immune checkpoint blocker, histone deacetylase inhibitor, oral vitamin A or other oral vitamin A analogue (eg acitretin, isotretinoin or tretinoin, also known as all-trans retinoic acid or ATRA) usage or possible use within next 12 months
- Current participation in another interventional HIV cure study
- Pregnancy or breast-feeding
- Participants of child-bearing potential unwilling to use at least one form of effective contraception (with failure rate <1%, eg hormonal contraception, intrauterine device, abstinence, tubal ligation or partner with vasectomy) from at least 2 weeks prior to study commencement until at least 4 weeks after discontinuation of all study medication
- Inability to consent
- Inability to speak English
- Medicare ineligibility
- Major medical or psychiatric illness or substance misuse that could in the opinion of the investigator impair adherence to the study protocol
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
The Peter Doherty Institute for Infection and Immunity
Melbourne, Victoria, 3000
The Alfred Hospital - Department of Infectious Diseases
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
About this study
Official title: Effect of High Dose Vitamin D Supplementation on HIV Latency: A Pilot Randomized Controlled Trial
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.
Read the detailed description
The major barrier to a cure for HIV infection is the persistence of latently infected CD4+ T cells on antiretroviral therapy (ART). HIV is concentrated in vivo in Th17 cells in blood and the gastrointestinal tract. Th17 cells are critical mediators of mucosal immunity against bacteria and fungi and are rapidly depleted in the gut following HIV acquisition with subsequent gut epithelial permeability, microbial translocation and ensuing chronic inflammation which is not completely reversed on ART. Such inflammation may contribute to HIV persistence by potentiating T cell proliferation and thereby clonal expansion of infected cells, by exacerbating CD8+ T cell exhaustion and potentially by promoting viral replication despite ART.
Vitamin D has pleiotropic effects on the immune system including directing naïve CD4+ T cells away from the Th17 phenotype toward an anti-inflammatory regulatory T cell phenotype. It may also have beneficial effects on dendritic cell and CD8+ T cell immunity. Furthermore, vitamin D has been shown in animal models to strengthen gut epithelial integrity and in healthy volunteers to promote a more diverse gut microbiome.
The investigators plan to perform a pilot randomized double-blind placebo-controlled trial of high dose vitamin D supplementation in HIV-infected participants on suppressive ART and to determine its effect on immune activation, Th17 cell frequency, gut barrier integrity, the gut microbiome and HIV persistence.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Vitamin D3, 10000 Intl Units Oral Capsule, Placebo oral capsule
- Keywords
- HIV, Inflammation, Vitamin D, Immunomodulation, Virus latency
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3, 10000 Intl Units Oral CapsuleDrug
Also called Treatment Group
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.
Placebo oral capsuleDrug
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3, 10000 Intl Units Oral Capsule | Active comparator | Vitamin D3, 10000 Intl Units Oral Capsule, daily for 6 months Receives: Drug: Vitamin D3, 10000 Intl Units Oral Capsule |
| Placebo oral capsule | Placebo comparator | Oleic acid capsule by mouth, daily for 6 months Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total HIV DNA level
The difference between the vitamin D and placebo arms in the mean change in frequency of total HIV DNA within CD4+ T cells from week 0 to week 24
Measured: weeks 0 and 24
Secondary outcomes (15)
Change in other DNA markers of HIV persistence
Total HIV DNA, integrated HIV DNA and 2-LTR circles in peripheral blood CD4+ T cells using PCR
Measured: Weeks 0, 12, 24, 36
Change in cell-associated HIV RNA
Cell-associated unspliced and multiply spliced HIV RNA in peripheral blood CD4+ T cells using RT-PCR and Tat/rev Induced Limiting Dilution Assay (TILDA)
Measured: Weeks 0, 12, 24, 36
Change in proportion of immune cells
T helper and T cytotoxic subsets, monocytes, dendritic cells and natural killer cells using flow cytometry
Measured: Weeks 0, 12, 24, 36
Change in T cell subset phenotype
T cell subset activation and exhaustion marker and chemokine receptor expression using flow cytometry
Measured: Weeks 0, 12, 24, 36
Change in HIV-specific immunity
HIV-specific CD4+ and CD8+ T cell frequency and polyfunctionality using HIV peptides and flow cytometry
Measured: Weeks 0, 12, 24, 36
Change in CD4+ T cell transcriptional profile
CD4+ T cell transcriptional profile using RNA Seq
Measured: Weeks 0, 12, 24, 36
Change in high sensitivity C-reactive protein (hsCRP)
hsCRP levels
Measured: Weeks 0, 12, 24, 36
Change in gut barrier permeability
Gut barrier permeability using plasma lipopolysaccharide (LPS), soluble CD14 and intestinal fatty acid binding protein (I-FABP)
Measured: Weeks 0, 12, 24, 36
Change in gut microbiome diversity
Gut microbiome diversity using 16S rRNA sequencing and metagenomics
Measured: Weeks 0, 24, 36
Change in plasma microbiome abundance and diversity
Plasma microbiome abundance and diversity using deep sequencing
Measured: Weeks 0, 24, 36
25-hydroxyvitamin D levels
Serum 25-hydroxyvitamin D levels and correlation between level achieved and each of the other endpoints (efficacy analysis)
Measured: Weeks 0, 12, 24, 36
Serum calcium levels
Serum calcium corrected for albumin
Measured: Weeks 0, 12, 24, 36
Urinary calcium levels
Urinary calcium:creatinine ratios and, where these are abnormal, 24 hour urinary calcium levels
Measured: Weeks 0, 12, 24, 36
Adverse events
Incidence and severity of adverse events
Measured: Weeks 0, 12, 24, 36
Study protocol adherence
Adherence to study drug and 1g daily dietary calcium intake as measured by pill count and participant report
Measured: Weeks 0 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start29 Jan 2018
- Primary completion21 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health, The Alfred, Melbourne Sexual Health Centre, University of Illinois Chicago, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Sharon Lewin, University of Melbourne
- Investigators
- Sharon Lewin, FRACP PhD, Principal investigator, The Peter Doherty Institute for Infection and Immunity, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426592
- Sponsor's protocol ID
- 2016.362
- Acronym
- VIVA
- Status last verified
- Jun 2019
- First submitted
- 1 Feb 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pitman MC, Meagher N, Price DJ, Rhodes A, Chang JJ, Scher B, Allan B, Street A, McMahon JH, Rasmussen TA, Cameron PU, Hoy JF, Kent SJ, Lewin SR. Effect of high dose vitamin D3 on the HIV-1 reservoir: A pilot randomised controlled trial. J Virus Erad. 2023 Aug 29;9(3):100345. doi: 10.1016/j.jve.2023.100345. eCollection 2023 Sep.
PubMed 37753336
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Dose Vitamin D Supplementation on HIV Latency: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03426592
- Acronym / sponsor ID
- VIVA / 2016.362
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Inflammation, Vitamin D, Immunomodulation, Virus latency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Melbourne Health, The Alfred, Melbourne Sexual Health Centre, University of Illinois Chicago, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The major barrier to a cure for HIV infection is the persistence of latently infected CD4+ T cells on antiretroviral therapy (ART). HIV is concentrated in vivo in Th17 cells in blood and the gastrointestinal tract. Th17 cells are critical mediators of mucosal immunity against bacteria and fungi and are rapidly depleted in the gut following HIV acquisition with subsequent gut epithelial permeability, microbial translocation and ensuing chronic inflammation which is not completely reversed on ART. Such inflammation may contribute to HIV persistence by potentiating T cell proliferation and thereby clonal expansion of infected cells, by exacerbating CD8+ T cell exhaustion and potentially by promoting viral replication despite ART.
Vitamin D has pleiotropic effects on the immune system including directing naïve CD4+ T cells away from the Th17 phenotype toward an anti-inflammatory regulatory T cell phenotype. It may also have beneficial effects on dendritic cell and CD8+ T cell immunity. Furthermore, vitamin D has been shown in animal models to strengthen gut epithelial integrity and in healthy volunteers to promote a more diverse gut microbiome.
The investigators plan to perform a pilot randomized double-blind placebo-controlled trial of high dose vitamin D supplementation in HIV-infected participants on suppressive ART and to determine its effect on immune activation, Th17 cell frequency, gut barrier integrity, the gut microbiome and HIV persistence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3, 10000 Intl Units Oral Capsule | Active comparator | Drug: Vitamin D3, 10000 Intl Units Oral CapsuleVitamin D3, 10000 Intl Units Oral Capsule, daily for 6 months |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleOleic acid capsule by mouth, daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent obtained
- At least 18 years of age
- Documented HIV-1 infection
- Receiving combination antiretroviral therapy continuously for at least 3 years
- Viral load suppressed below 40 copies/mL, or below assay limit of quantification where limit of quantification is above 40 copies/mL, for at least 3 years (excluding single episodes of HIV viral load 40-500 copies/mL where subsequent viral load was below 40 copies/mL or below assay limit of quantification where limit of quantification is above 40 copies/mL)
Key exclusion criteria (22 listed)
- Any planned change to ART regimen within next 12 months (other than switching tenofovir disoproxil fumarate to tenofovir alafenamide)
- Known current acute or chronic hepatitis B, known current acute or chronic hepatitis C or positive HBsAg or HCV PCR in blood at screening
- Completion of curative treatment for HCV within 6 months prior to screening
- HIV-2 infection
- Any vitamin D supplementation from 6 months prior to the screening 25(OH) vitamin D test until study commencement (including multivitamins containing vitamin D and cod liver oil)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3, 10000 Intl Units Oral CapsuleAlso: Treatment GroupVitamin 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 | Vitamin D3, 10000 Intl Units Oral Capsule |
| Placebo oral capsuleAlso: Control GroupCapsule 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. | Drug | Placebo oral capsule |
Primary outcome
Change in total HIV DNA level
Time frame: weeks 0 and 24
The difference between the vitamin D and placebo arms in the mean change in frequency of total HIV DNA within CD4+ T cells from week 0 to week 24
15 secondary outcomes
Change in other DNA markers of HIV persistence
Time frame: Weeks 0, 12, 24, 36
Change in cell-associated HIV RNA
Time frame: Weeks 0, 12, 24, 36
Change in proportion of immune cells
Time frame: Weeks 0, 12, 24, 36
Change in T cell subset phenotype
Time frame: Weeks 0, 12, 24, 36
Change in HIV-specific immunity
Time frame: Weeks 0, 12, 24, 36
Change in CD4+ T cell transcriptional profile
Time frame: Weeks 0, 12, 24, 36
Change in high sensitivity C-reactive protein (hsCRP)
Time frame: Weeks 0, 12, 24, 36
Change in gut barrier permeability
Time frame: Weeks 0, 12, 24, 36
Change in gut microbiome diversity
Time frame: Weeks 0, 24, 36
Change in plasma microbiome abundance and diversity
Time frame: Weeks 0, 24, 36
25-hydroxyvitamin D levels
Time frame: Weeks 0, 12, 24, 36
Serum calcium levels
Time frame: Weeks 0, 12, 24, 36
Urinary calcium levels
Time frame: Weeks 0, 12, 24, 36
Adverse events
Time frame: Weeks 0, 12, 24, 36
Study protocol adherence
Time frame: Weeks 0 to 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 37753336Pitman MC, Meagher N, Price DJ, Rhodes A, Chang JJ, Scher B, Allan B, Street A, McMahon JH, Rasmussen TA, Cameron PU, Hoy JF, Kent SJ, Lewin SR. Effect of high dose vitamin D3 on the HIV-1 reservoir: A pilot randomised controlled trial. J Virus Erad. 2023 Aug 29;9(3):100345. doi: 10.1016/j.jve.2023.100345. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Lewin, FRACP PhD principal investigator
The Peter Doherty Institute for Infection and Immunity, University of Melbourne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3, 10000 Intl Units Oral Capsule in people with Human Immunodeficiency Virus, run by University of Melbourne at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total HIV DNA level (time frame: weeks 0 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.