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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)

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ClinicalTrials.gov Identifier: NCT02652793
Recruitment Status : Unknown
Verified August 2016 by David Garcia Cinca, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : January 12, 2016
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
David Garcia Cinca, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Drug: Boosted atazanavir Drug: Lamivudine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. Change in bone mineral density by dual-energy X-ray absorptiometry in human immunodeficiency virus-infected adults with hip or spine T-score between < -1.0 and >-2.5 by dual-energy X-ray absorptiometry [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients free of virologic failure (confirmed viral load≥ 50 copies/mL) [ Time Frame: 48 weeks ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652793


Contacts
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Contact: Jose Luís Blanco, MD +34 93 227 54 00
Contact: David Garcia Cinca dgarcia@clinic.ub.es

Locations
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Spain
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Jose Luis Blanco, MD    +34 93 227 54 00      
Sponsors and Collaborators
David Garcia Cinca
Fundacion Clinic per a la Recerca Biomédica

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Responsible Party: David Garcia Cinca, Clinical Research Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02652793     History of Changes
Other Study ID Numbers: 2014-002720-27
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Lamivudine
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Bone Diseases, Metabolic
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ritonavir
Atazanavir Sulfate
HIV Protease Inhibitors
Tenofovir
Emtricitabine
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors