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

NCT ID: NCT02652793

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily.

Group Type: EXPERIMENTAL

Boosted atazanavir

Intervention Type: DRUG

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

Lamivudine

Intervention Type: DRUG

Lamivudine 300 mg once dailly

Interventions

Boosted atazanavir

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

Intervention Type: DRUG

Lamivudine

Lamivudine 300 mg once dailly

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: collaborator

Judit Pich

OTHER

Sponsor Role: lead

Responsible Party

Judit Pich

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-002720-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Osteosimply014

Identifier Type: -

Identifier Source: org_study_id