Phase 4 Study of Bone Mineral Density in HIV-1 Infected Subjects
Research type
Research Study
Full title
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
IRAS ID
118939
Contact name
Chloe Orkin
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2011-004420-35
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
This is a Phase 4 cross-sectional study of Bone Mineral Density in HIV-1 infected subjects.
A range of bone disorders have been reported in association with HIV infection. Bone demineralisation is a common disorder in HIV-1 infected patients, with up to 67% of patients with reduced Bone Mineral Density. Compared with uninfected subjects, HIV-1 infected patients have a 6.4 fold higher risk of decreased Bone Mineral Density.
Bone Mineral Density has been found to be decreased in older HIV-infected patients and in patients on HIV treatment; in previous studies it was shown that there were decreases in Bone Mineral Density found through the first 48 weeks of Anti-Retroviral Therapy with stabilization thereafter.The purpose of the study is to characterize the profile of low Bone Mineral Density in ≥ 50 years old male HIV-1 infected subjects and post-menopausal female HIV-1 infected subjects taking Tenofovir Disoproxil Fumarate (TDF)-based regimens relative to those taking non-TDF-based regimens for HIV infection.
Four groups of males ≥ 50 years of age and four groups of postmenopausal females on regimens containing either TDF or non- TDF based NRTIs as part of either ritonavir-boosted protease inhibitor (PI/r) or non-PI/r regimen will be included. There will be 60 participants in each group, with 480 subjects in total (240 female and 240 male).
Patients will participate in a single study visit, procedures performed during this visit include: Medical History, Blood Test, Urine Test, and DEXA scan. If the scan cannot be performed on the same day as the study visit, it can occur within 30 days; this is the maximum length of time the patient will be in the study.
This study is sponsored by Gilead. Approximately 480 patients from 100 sites in Europe will participate, with approximately 65 patients expected in the UK.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/0766
Date of REC Opinion
4 Jul 2013
REC opinion
Further Information Favourable Opinion