E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020188 |
E.1.2 | Term | HIV test positive |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063206 |
E.1.2 | Term | HIV-1 test positive |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effects of vit D supplementation on markers of the immune system, specifically CD4+CD25+ T-regulatory cells |
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E.2.2 | Secondary objectives of the trial |
To determine the benefits of a one high dose of Colecalciferol (200,000 U orally) on serum vit D levels in patients with HIV infection after 12 weeks from commencement of Vitamin D supplementation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Aged between 18 years and 45 years , Males and Females
Documented Positive HIV-1 antibody test and either stable on HAART as defined by undetectable viral load and on the same regimen for ≥6 months or treatment naive (HIV+ cohort only) (n=32)
Presumed HIV negative –(HIV negative cohort only) (n=16)
Ability to give informed consent
Females willing to use barrier method contraception (condoms) for the duration of the trial.
Documented Vitamin D deficiency (less than 50 nmol/L within 6 months of screening)
Not currently taking Vitamin D supplements, or has taken any Vitamin D supplements within 4 weeks of screening
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E.4 | Principal exclusion criteria |
Pregnancy or breast feeding
Patient unlikely to comply with protocol
1Received vitamin D supplementation within the previous 4 weeks.
Documented history of renal impairment
Any chronic inflammatory condition
Documented Hepatitis B or C
Documented soya or peanut allergy or hypersensitivity to any of the constituents of Dekristol®
Hypercalcaemia or hypercalciuria
Pseudohypoparathyroidism
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E.5 End points |
E.5.1 | Primary end point(s) |
The Primary endpoint will be T-regulatory cell numbers at 12 weeks. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints:
Serum vitamin D levels at week 4 and 12.
Change in immune parameters such as T-regulatory function at weeks 4 and 12, and numbers at 4 weeks.
Plasma IL-10, TNF α, IFN λ, IL-17 at 4 and 12 weeks.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Comparison between patient groups |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 16 |
E.8.9.2 | In all countries concerned by the trial days | 0 |