EUCTR2011-004420-35-ES
Active, not recruiting
Not Applicable
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 480
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •? 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 ARV regimen for ? 3 years are allowed (withinclass change of agents other than TDF within 3 years of study entry
- •are permitted as specified):
- •? a 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 a 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
Exclusion Criteria
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •? Have a contraindication to dual\-energy X\-ray absorptiometry (DEXA) scans
- •? Have a history of osteoporosis before initiating highly active antriretroviral therapy
Investigators
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