GS-US-104-0423

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)

Go to download area

Responsibilities in overall study

Sponsor

Gilead Sciences, Inc.

(National) Coordinating Investigator

Prof. Dr. med. Christoph Stephan