Status | Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|---|
Active | GS-US-104-0423 | 2011-004420-34 |
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Purpose / Objectives
Primary Outcome
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 regimen relative to
those on any non-TDF-based regimen for HIV infection.
Diagnosis
- HIV-1
- Infectiology/HIV and AIDS
HIV-infected
Target population
Disease stage
treated patients
Age
50-99
Inclusion criteria
- HIV-1 infected subjects regardless of race or ethnicity
- Use of a stable, continuous,NRTI-containing ARV regimen for ≥ 3 years are allowed change of agents other than TDF within 3 years of study entry
- 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 nonboosted
protease inhibitors. - Male subjects must be ≥ 50 years of age
- Female subjects must be postmenopausal.
Exclusion criteria
- Subject has a contraindication to DEXA scans
- Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
Study design
- Phase IV
- Multicenter
- Prospective
- One-arm
Intervention
Dexa-Scan
Documents (password protected)
Responsibilities in overall study
Sponsor
Gilead Sciences, Inc.
(National) Coordinating Investigator
Prof. Dr. med. Christoph Stephan