EUCTR2011-004420-35-PT
Active, not recruiting
Not Applicable
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Immunodeficiency Virus-1 (HIV-1) Infections
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 480
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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