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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002720-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | All participants will switch their current antiretroviral regimen to a boosted atazanavir and lamivudine once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boosted atazanavir | Drug | Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL) | 48 weeks | |
| Proportion of Patients With Adverse Effects | 48 weeks | |
| Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain |
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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2014 |
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| Lamivudine | Drug | Lamivudine 300 mg once dailly |
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| 48 weeks |
| Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase | 48 weeks |
| Renald Disfunction Parameter: Estimated Glomerular Filtration Rate | 48 weeks |
| Renald Disfunction Parameter: Phosphorus in Blood Sample | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples | 48 weeks |
| Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples | 48 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Of the 31 participants enrolled, 1 did not initiate treatment after screening and was excluded from all analyses. Therefore, the baseline and analysis population included 30 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Bone Mineral Density (BMD) at Baseline by DXA | Median | Inter-Quartile Range | g/cm² |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | g/cm² | Baseline to Week 48 |
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| Secondary | Proportion of Patients Free of Virologic Failure (Confirmed Viral Load≥ 50 Copies/mL) | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Adverse Effects | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Bone Turnover Markers in Blood: Urinary N-terminal Telopeptide of Type-1 Collagen | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Bone Turnover Markers in Blood: Bone-specific Alkaline Phosphatase | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction Parameter: Estimated Glomerular Filtration Rate | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction Parameter: Phosphorus in Blood Sample | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: Glucose in Urine | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: Protein in Urine Samples | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: Albumin in Urine Samples | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: Creatinin in Urine Samples | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: Phosphorus in Urine Samples | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: Beta-2 Microglobulin in Urine Samples | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renald Disfunction, Tubule Dysfunction, Parameter: N-Acetyl-β-D Glucosaminidase in Urine Samples | Not Posted | 48 weeks | Participants |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 30 | 0 | 30 | 2 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
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This pilot study had a small sample size and did not reach the planned enrollment of 45 participants.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. José Luis Blanco | Hospital Clinic of Barcelona | +34 932275400 | jlblanco@clinic.cat |
| Jun 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.
| Single-arm study; no comparator group | Regression, Linear | Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48. | 0.0046 | Left hip | Mean Difference (Final Values) | 0.013 | Standard Deviation | 0.03 | 2-Sided | 95 | 0.004 | 0.023 | Represents mean change in left hip BMD from baseline to Week 48 | Superiority | Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants. |