Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia (Osteosimply014)

A 48-week, open label, non comparative prospective trial in stable chronic human immunodeficiency virus-infected patients having achieved complete virological suppression for more than 24 weeks (human immunodeficiency virus-1 RNA <50 c/ml) switching from an antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at screening, baseline, weeks 4, 12, 24, and 48.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Boosted atazanavir; Drug: Lamivudine

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic I Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Human immunodeficiency virus-1-infected subjects with age ≥18 years old
• Hip or spine T-scores between < -1.0 and >-2.5 by dual-energy X-ray absorptiometry (in the previous 24 weeks)
• Stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks.
• Having plasma human immunodeficiency virus-1 RNA <50 copies/mL for at least the previous 24 weeks, including at least two samples.

Exclusion Criteria:

• Pregnancy, breast-feeding status or plans for pregnancy in the short term
• Primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine
• Chronic hepatitis B infection
• Patients with indication for therapy for the prevention of bone fractures
• 25-OH vitamin D deficiency (< 10ng/mL)
• Hypogonadism (low total testosterone according to local reference range)
• Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges)
• Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges)
• Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more)
• Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated)
• Body mass index lower than 19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.	Drug: Boosted atazanavir; Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly; Drug: Lamivudine; Lamivudine 300 mg once dailly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48	Mean change in BMD (g/cm²) at lumbar spine (L1-L4) and left hip measured by dual-energy X-ray absorptiometry (DXA) in human immunodeficiency virus-infected adults with hip or spine T-score between < -1.0 and >-2.5	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)	48 weeks
Proportion of Patients With Adverse Effects	48 weeks
Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen	48 weeks
Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase	48 weeks
Renald Disfunction Parameter: Estimated Glomerular Filtration Rate	48 weeks
Renald Disfunction Parameter: Phosphorus in Blood Sample	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples	48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples	48 weeks

Collaborators and Investigators

• Sponsor: Judit Pich
• Collaborators: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: December 31, 2015
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimated): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Bone Diseases, Metabolic; Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Protease Inhibitors; Atazanavir Sulfate; Lamivudine
• Other Study ID Numbers: Osteosimply014; 2014-002720-27 (EudraCT Number)