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OpenTrials
Completed

NCT Number: NCT02652793

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boosted atazanavir

Drug

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

Lamivudine

Drug

Lamivudine 300 mg once dailly

Primary outcomes

  1. Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48

    Time frame: 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

Secondary outcomes

  1. Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)

    Time frame: 48 weeks

  2. Proportion of Patients With Adverse Effects

    Time frame: 48 weeks

  3. Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen

    Time frame: 48 weeks

  4. Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase

    Time frame: 48 weeks

  5. Renald Disfunction Parameter: Estimated Glomerular Filtration Rate

    Time frame: 48 weeks

  6. Renald Disfunction Parameter: Phosphorus in Blood Sample

    Time frame: 48 weeks

  7. Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine

    Time frame: 48 weeks

  8. Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples

    Time frame: 48 weeks

  9. Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples

    Time frame: 48 weeks

  10. Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples

    Time frame: 48 weeks

  11. Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples

    Time frame: 48 weeks

  12. Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples

    Time frame: 48 weeks

  13. Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Judit Pich

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2016
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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