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.
- Conditions
- HIV infected patients with vitamin D defficiencyMedDRA version: 14.1Level: LLTClassification code 10020189Term: HIV test positveSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: LLTClassification code 10020180Term: HIV positiveSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10020181Term: HIV positveSystem Organ Class: 10022891 - InvestigationsTherapeutic 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
-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
-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
Name Time Method
- Secondary Outcome Measures
Name Time Method