N/A
N=31
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
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02652793 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48 — 0.010; 0.013 g/cm² — p=0.0239
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boosted atazanavir (Drug); Lamivudine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Judit Pich
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48 |
0.010; 0.013 | 0.0239 sig |
| SECONDARY Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL) |
— | — |
| SECONDARY Proportion of Patients With Adverse Effects |
— | — |
| SECONDARY Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen |
— | — |
| SECONDARY Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase |
— | — |
| SECONDARY Renald Disfunction Parameter: Estimated Glomerular Filtration Rate |
— | — |
| SECONDARY Renald Disfunction Parameter: Phosphorus in Blood Sample |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples |
— | — |
| SECONDARY Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Human immunodeficiency virus-1-infected subjects with age ≥18 years old
- Hip or spine T-scores between -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
Data sourced from ClinicalTrials.gov (NCT02652793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.