Clinical trial NCT02652793: 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
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
Overall status: UNKNOWN
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2016-01-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of patients free of virologic failure (confirmed viral load≥ 50 copies/mL)
timeFrame: 48 weeks
measure: Adverse effects
timeFrame: 48 weeks
measure: Bone turnover markers in blood: urinary N-terminal telopeptide of type-1 collagen
timeFrame: 48 weeks
measure: Bone turnover markers in blood: bone-specific alkaline phosphatase
timeFrame: 48 weeks
measure: Renald disfunction parameter: estimated glomerular filtration rate
timeFrame: 48 weeks
measure: Renald disfunction parameter: phosphorus in blood sample
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: glucose in urine
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: protein in urine samples
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: albumin in urine samples
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: creatinin in urine samples
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: phosphorus in urine samples
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: beta-2 microglobulin in urine samples
timeFrame: 48 weeks
measure: Renald disfunction, tubule dysfunction, parameter: N-Acetyl-β-D Glucosaminidase in urine samples
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
Study officials:
References: