Human Immunodeficiency VirusNCT02652793

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

A study testing Boosted atazanavir and Lamivudine in people with Human Immunodeficiency Virus, run by Judit Pich at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Boosted atazanavir and Lamivudine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteSpain
Study dates: Nov 2015to Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

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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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínic i Provincial de Barcelona
Barcelona, 08036

Other trials in Spain

About this study

Conditions: Human Immunodeficiency Virus
Being tested: Boosted atazanavir, Lamivudine
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Boosted atazanavirDrug
Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly
LamivudineDrug
Lamivudine 300 mg once dailly

Study groups in NCT02652793
Study group	Role	What they receive
Experimental	Experimental	All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily. Receives: Drug: Boosted atazanavir; Drug: Lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline to Week 48

Secondary outcomes (13)

Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)
Measured: 48 weeks
Proportion of Patients With Adverse Effects
Measured: 48 weeks
Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen
Measured: 48 weeks
Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase
Measured: 48 weeks
Renald Disfunction Parameter: Estimated Glomerular Filtration Rate
Measured: 48 weeks
Renald Disfunction Parameter: Phosphorus in Blood Sample
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples
Measured: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Nov 2018

First posted12 Jan 2016 (estimated)
Study startNov 2015
Primary completionNov 2018
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02652793
Sponsor's protocol ID: Osteosimply014
Other IDs: 2014-002720-27, 2014
Status last verified: Jun 2025
First submitted: 31 Dec 2015
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02652793
Acronym / sponsor ID: Osteosimply014
Conditions: Human Immunodeficiency Virus
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Judit PichUniversity, hospital or other
Collaborators: Fundacion Clinic per a la Recerca Biomédica
Study start: Nov 2015 (actual)
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 12 Jan 2016 (estimated)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Drug: Boosted atazanavir, Drug: LamivudineAll participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Boosted atazanavirAtanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly	Drug	Experimental
LamivudineLamivudine 300 mg once dailly	Drug	Experimental

Primary outcome

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

13 secondary outcomes

Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL)
Time frame: 48 weeks
Proportion of Patients With Adverse Effects
Time frame: 48 weeks
Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen
Time frame: 48 weeks
Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase
Time frame: 48 weeks
Renald Disfunction Parameter: Estimated Glomerular Filtration Rate
Time frame: 48 weeks
Renald Disfunction Parameter: Phosphorus in Blood Sample
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples
Time frame: 48 weeks
Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples
Time frame: 48 weeks

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RTV-Boosted-ATV + 3TC	31	27

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

Time frame: Baseline to Week 48. Mean (Standard Deviation). Unit: g/cm²

Measure	RTV-Boosted-ATV + 3TC n = 30
Lumbar Spine	0.010 (0.030)
Left Hip	0.013 (0.030)

RTV-Boosted-ATV + 3TC: Mean Difference (Final Values): 0.010 (95% CI 0.001 to 0.019), p = 0.0239, Regression, Linear
RTV-Boosted-ATV + 3TC: Mean Difference (Final Values): 0.013 (95% CI 0.004 to 0.023), p = 0.0046, Regression, Linear

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From informed consent to Week 48 (end of study visit). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RTV-Boosted-ATV + 3TC	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30

Limitations and caveats (from the sponsor): This pilot study had a small sample size and did not reach the planned enrollment of 45 participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Boosted atazanavir and Lamivudine in people with Human Immunodeficiency Virus, run by Judit Pich at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48 (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02652793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.