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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02652793
Enrollment
31
Registered
2016-01-12
Start date
2015-11-30
Completion date
2018-11-30
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

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.

Interventions

DRUGLamivudine

Lamivudine 300 mg once dailly

DRUGBoosted atazanavir

Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly

Sponsors

Fundacion Clinic per a la Recerca Biomédica
CollaboratorOTHER
Judit Pich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48Baseline to Week 48Mean change in BMD (g/cm²) at lumbar spine (L1-L4) and left hip measured by dual-energy X-ray absorptiometry (DXA) in human immunodeficiency virus-infected adults with hip or spine T-score between \< -1.0 and \>-2.5

Secondary

MeasureTime frame
Proportion of Patients With Adverse Effects48 weeks
Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen48 weeks
Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase48 weeks
Renald Disfunction Parameter: Estimated Glomerular Filtration Rate48 weeks
Renald Disfunction Parameter: Phosphorus in Blood Sample48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine48 weeks
Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples48 weeks

Countries

Spain

Participant flow

Recruitment details

Participants were recruited at a single center (Infectious Diseases Department, Hospital Clínic, University of Barcelona) between November 2015 and November 2017. Recruitment targeted virologically suppressed HIV-infected adults with osteopenia receiving tenofovir-based ART.

Pre-assignment details

Of the 60 individuals screened, 29 were excluded prior to assignment due to normal bone mineral density, prior virological failure, hypogonadism, or contraindicated medications. A total of 31 participants were enrolled and switched to the study regimen.

Participants by arm

ArmCount
RTV-Boosted-ATV + 3TC
Participants switched from a stable antiretroviral regimen containing tenofovir disoproxil fumarate plus lamivudine or emtricitabine plus ritonavir-boosted protease inhibitor to a simplified regimen of ritonavir-boosted atazanavir (300/100 mg) plus lamivudine (300 mg) once daily for 48 weeks.
30
Total30

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1
Overall StudyLost to Follow-up2
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicRTV-Boosted-ATV + 3TC
Age, Continuous40 years
Bone Mineral Density (BMD) at Baseline by DXA
Left Hip
0.72 g/cm²
Bone Mineral Density (BMD) at Baseline by DXA
Lumbar Spine
0.88 g/cm²
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
30 Participants
Region of Enrollment
Spain
30 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
26 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
2 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48

Mean change in BMD (g/cm²) at lumbar spine (L1-L4) and left hip measured by dual-energy X-ray absorptiometry (DXA) in human immunodeficiency virus-infected adults with hip or spine T-score between \< -1.0 and \>-2.5

Time frame: Baseline to Week 48

ArmMeasureGroupValue (MEAN)Dispersion
RTV-Boosted-ATV + 3TCChange in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48Lumbar Spine0.010 g/cm²Standard Deviation 0.03
RTV-Boosted-ATV + 3TCChange in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48Left Hip0.013 g/cm²Standard Deviation 0.03
Comparison: Single-arm study; no comparator groupp-value: 0.023995% CI: [0.001, 0.019]Regression, Linear
Comparison: Single-arm study; no comparator groupp-value: 0.004695% CI: [0.004, 0.023]Regression, Linear
Secondary

Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase

Time frame: 48 weeks

Secondary

Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen

Time frame: 48 weeks

Secondary

Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)

Time frame: 48 weeks

Secondary

Proportion of Patients With Adverse Effects

Time frame: 48 weeks

Secondary

Renald Disfunction Parameter: Estimated Glomerular Filtration Rate

Time frame: 48 weeks

Secondary

Renald Disfunction Parameter: Phosphorus in Blood Sample

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples

Time frame: 48 weeks

Secondary

Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples

Time frame: 48 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026