EUCTR2010-023122-21-GB
Active, not recruiting
Phase 1
Pro-Bono 2- A prospective study of loss of bone mineral density in patients with HIV over time: implications for clinical practice and therapeutic options: Vitamin D sub study. - Pro-Bono-2 Vitamin D SubStudy
ConditionsHIVMedDRA version: 20.0 Level: PT Classification code 10020188 Term: HIV test positive System Organ Class: 10022891 - InvestigationsMedDRA version: 20.0 Level: LLT Classification code 10063206 Term: HIV-1 test positive System Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsDekristol
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- King's College London
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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
Investigators
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