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

NCT02652793 | Completed Results

• 2 other identifiers: Osteosimply0142014-002720-27
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.

Drug: Boosted atazanavir; Drug: Lamivudine

Interventions

Boosted atazanavir DRUG

Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly

Experimental

Lamivudine DRUG

Lamivudine 300 mg once dailly

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Judit Pich: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Limitations and Caveats

This pilot study had a small sample size and did not reach the planned enrollment of 45 participants.

Results Point of Contact

• Title: Dr. José Luis Blanco
• Organization: Hospital Clinic of Barcelona

jlblanco@clinic.cat

+34 932275400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 12, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Locations

ES (1)