Back to resultsSimplification 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)
Primary Purpose
Human Immunodeficiency Virus
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Boosted atazanavir
Lamivudine
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus
Eligibility 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
Sites / Locations
- Hospital Clínic i Provincial de BarcelonaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of patients free of virologic failure (confirmed viral load≥ 50 copies/mL)
Adverse effects
Bone turnover markers in blood: urinary N-terminal telopeptide of type-1 collagen
Bone turnover markers in blood: bone-specific alkaline phosphatase
Renald disfunction parameter: estimated glomerular filtration rate
Renald disfunction parameter: phosphorus in blood sample
Renald disfunction, tubule dysfunction, parameter: glucose in urine
Renald disfunction, tubule dysfunction, parameter: protein in urine samples
Renald disfunction, tubule dysfunction, parameter: albumin in urine samples
Renald disfunction, tubule dysfunction, parameter: creatinin in urine samples
Renald disfunction, tubule dysfunction, parameter: phosphorus in urine samples
Renald disfunction, tubule dysfunction, parameter: beta-2 microglobulin in urine samples
Renald disfunction, tubule dysfunction, parameter: N-Acetyl-β-D Glucosaminidase in urine samples
Full Information
NCT ID
NCT02652793
First Posted
December 31, 2015
Last Updated
August 16, 2016
Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT02652793
Brief 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
Acronym
Osteosimply014
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.
Intervention Type
Drug
Intervention Name(s)
Boosted atazanavir
Intervention Description
Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
Lamivudine 300 mg once dailly
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of patients free of virologic failure (confirmed viral load≥ 50 copies/mL)
Time Frame
48 weeks
Title
Adverse effects
Time Frame
48 weeks
Title
Bone turnover markers in blood: urinary N-terminal telopeptide of type-1 collagen
Time Frame
48 weeks
Title
Bone turnover markers in blood: bone-specific alkaline phosphatase
Time Frame
48 weeks
Title
Renald disfunction parameter: estimated glomerular filtration rate
Time Frame
48 weeks
Title
Renald disfunction parameter: phosphorus in blood sample
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: glucose in urine
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: protein in urine samples
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: albumin in urine samples
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: creatinin in urine samples
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: phosphorus in urine samples
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: beta-2 microglobulin in urine samples
Time Frame
48 weeks
Title
Renald disfunction, tubule dysfunction, parameter: N-Acetyl-β-D Glucosaminidase in urine samples
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Luís Blanco, MD
Phone
+34 93 227 54 00
First Name & Middle Initial & Last Name or Official Title & Degree
David Garcia Cinca
Email
dgarcia@clinic.ub.es
Facility Information:
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Luis Blanco, MD
Phone
+34 93 227 54 00
12. IPD Sharing Statement
Learn more about this trial
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
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