Status:
COMPLETED
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
50+ years
Brief Summary
A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based reg...
Eligibility Criteria
Inclusion
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- HIV-1 infected subjects regardless of race or ethnicity
- Use of one of the following taken as a stable, continuous, NRTI-containing antiretroviral (ARV) regimen for ≥ 3 years are allowed (within-class change of agents other than TDF within 3 years of study entry are permitted as specified):
- TDF plus PI/r-containing regimen including subjects who switched from one TDF plus PI/r regimen to another TDF plus PI/r regimen
- a TDF plus non-PI/r-containing regimen including subjects who switched from one TDF plus non-PI/r regimen to another TDF plus non-PI/r regimen
- a Non-TDF NRTI plus a PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus PI/r regimen to another non-TDF NRTI regimen plus PI/r regimen
- a Non-TDF NRTI plus a non-PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus non-PI/r regimen to another non-TDF NRTI regimen plus non-PI/r regimen
- Of note, subjects in the non-TDF groups must have never taken a regimen that includes TDF (including previous exposure to TDF for pre-exposure prophylaxis (PrEP))
- Subjects included in the TDF groups must have always taken a regimen that includes TDF. Non-PI/r agents include non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors, triple nucleoside inhibitors and non-boosted protease inhibitors
- Male subjects must be ≥ 50 years of age
- Female subjects must be postmenopausal. Menopause can be assumed to have occurred in a woman when there is either appropriate medical documentation of prior complete bilateral oophorectomy or permanent cessation of previously occurring menses \> 12 months as a result of ovarian failure or bilateral oophorectomy with documentation of hormonal deficiency by a certified healthcare provided
- Adequate records available to evaluate medical history for the 3 years prior to study entry
Exclusion
- Subject has a contraindication to dual-energy X-ray absorptiometry (DEXA) scans
- Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT01850212
Start Date
February 1 2013
End Date
October 1 2014
Last Update
October 31 2014
Active Locations (73)
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1
LKH Graz West
Graz, Austria, A-8020
2
Medizinische Universitaet Innsbruck
Innsbruck, Austria, A6020
3
AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, Austria, A-4021
4
Otto Wagner Spital
Vienna, Austria, 1140