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This is a pilot study to see how giving HIV infected patients, who have Vitamin D deficiency (and are already taking standard therapy) a high dose of vitamin D will affect the levels of vitamin D in their bodies and if this will help them have a better immune response to their infection.

Phase 1
Conditions
HIV infected patients with vitamin D defficiency
MedDRA version: 14.1Level: LLTClassification code 10020189Term: HIV test positveSystem Organ Class: 10022891 - Investigations
MedDRA version: 14.1Level: LLTClassification code 10020180Term: HIV positiveSystem Organ Class: 10022891 - Investigations
MedDRA version: 14.1Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10020181Term: HIV positveSystem Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Registration Number
EUCTR2010-022775-57-GB
Lead Sponsor
Guy's and St Thomas' NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

-Male and female
-HIV infected patients on antiretroviral therapy
- Between 18-65 years of age
-Vitamin D deficiency [25(OH) vit D <40 nmol/L].
-Females must be willing to use barrier method contraception for the duration of the study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-HIV infected individuals not receiving antiretroviral therapy.
-Patients with normal Vitamin D levels (> 40 mmol/L)
-Patients taking Vitamin D supplements
-Documented soya or peanut allergy
-Patients unable to provide written consent or comply with protocol
-Pregnancy or trying to become pregnant
-Documented osteoporosis requiring treatment
-Participation on any other interventional study.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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