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)

D

David Garcia Cinca

Status

Unknown

Conditions

Human Immunodeficiency Virus

Treatments

Drug: Boosted atazanavir
Drug: Lamivudine

Study type

Interventional

Funder types

Other

Identifiers

NCT02652793
2014-002720-27

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Experimental
Experimental group
Description:
All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.
Treatment:
Drug: Lamivudine
Drug: Boosted atazanavir

Trial contacts and locations

1

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Central trial contact

Jose Luís Blanco, MD; David Garcia Cinca

Data sourced from clinicaltrials.gov

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