Trial Outcomes & Findings for 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 NCT02652793)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Baseline to Week 48

Results posted on

2025-07-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	31
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RTV-Boosted-ATV + 3TC n=30 Participants 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.
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Spain	30 Participants n=5 Participants
Bone Mineral Density (BMD) at Baseline by DXA Lumbar Spine	0.88 g/cm² n=5 Participants
Bone Mineral Density (BMD) at Baseline by DXA Left Hip	0.72 g/cm² n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	RTV-Boosted-ATV + 3TC n=30 Participants 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.
Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48 Lumbar Spine	0.010 g/cm² Standard Deviation 0.030
Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48 Left Hip	0.013 g/cm² Standard Deviation 0.030

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RTV-Boosted-ATV + 3TC n=30 participants at risk 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.
Hepatobiliary disorders Hyperbilirubinaemia	6.7% 2/30 • Number of events 2 • From informed consent to Week 48 (end of study visit) Adverse events were collected from the time of informed consent until the final study visit (Week 48). Severity was graded using the AIDS Clinical Trial Group (ACTG) Grading Scale. All AEs were recorded regardless of suspected relationship to study drug. Serious adverse events were defined per ICH-GCP guidelines.

Additional Information

Dr. José Luis Blanco

Hospital Clinic of Barcelona

Phone: +34 932275400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place