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 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02652793
• Other study ID #: 2014-002720-27
• Status: Recruiting
• Phase: N/A
• First received: December 31, 2015
• Last updated: August 16, 2016
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Hospital Clinic of Barcelona
• Contact: Jose Luís Blanco, MD
• Phone: +34 93 227 54 00
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Bone Diseases, Metabolic
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Boosted atazanavir
Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly
• Lamivudine
Lamivudine 300 mg once dailly

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
David Garcia Cinca	Jose Luis Blanco - Fundació Clínic per a la Recerca Biomèdica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		48 weeks	Yes
Secondary	Proportion of patients free of virologic failure (confirmed viral load= 50 copies/mL)		48 weeks	No
Secondary	Adverse effects		48 weeks	Yes
Secondary	Bone turnover markers in blood: urinary N-terminal telopeptide of type-1 collagen		48 weeks	Yes
Secondary	Bone turnover markers in blood: bone-specific alkaline phosphatase		48 weeks	Yes
Secondary	Renald disfunction parameter: estimated glomerular filtration rate		48 weeks	Yes
Secondary	Renald disfunction parameter: phosphorus in blood sample		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: glucose in urine		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: protein in urine samples		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: albumin in urine samples		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: creatinin in urine samples		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: phosphorus in urine samples		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: beta-2 microglobulin in urine samples		48 weeks	Yes
Secondary	Renald disfunction, tubule dysfunction, parameter: N-Acetyl-ß-D Glucosaminidase in urine samples		48 weeks	Yes