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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Holdsworth House Medical Practice | OTHER |
| The Alfred | OTHER |
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The purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with HIV infection who switch their HIV medication tenofovir to another HIV medication raltegravir.
Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic patients switching from ART including tenofovir disoproxil fumarate (TDF) and a ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips | Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96 | from Baseline to Weeks 48 and 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV Viral Load <50 Copies/mL | Plasma HIV viral load remained <50 copies/mL | from Baseline to Week 96 |
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Inclusion Criteria:
provision of written, informed consent
HIV-infected adults at least 18 years of age
receiving stable ART including TDF and a r/PI for the previous 6 months
no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
plasma HIV RNA < 50 copies/ml for at least the previous 3 months
spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)
Exclusion Criteria:
participation in any other clinical trial (unless approved by the study PI)
use of TDF for previously active chronic hepatitis B infection
receiving or requiring therapy for low BMD (including prior fragility fracture)
using oral corticosteroids or inhaled fluticasone
virological failure on, or intolerance to, RAL
contra-indication to RAL therapy (see appendix 2)
breast-feeding
pregnancy
secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency, hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone > 25% below lower limit of reference range and/or luteinizing hormone > 2 x upper limit of normal (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference ranges
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Carr, Professor | St Vincents Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Sydney Doctors | Sydney | New South Wales | 2010 | Australia | ||
| Holdsworth Medical Practice |
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir | Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir | Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips | Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96 | Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures. | Posted | Mean | 95% Confidence Interval | percent change | from Baseline to Weeks 48 and 96 |
|
at 48 and 96 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
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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 | Raltegravir | Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PARTNER PREGNANCY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Cramps | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Andrew Carr | St Vincents Hospital | +61 2 8382 3359 | andrew.carr@svha.org.au |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sydney |
| New South Wales |
| 2010 |
| Australia |
| St Vincents Hospital | Sydney | New South Wales | 2010 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Percentage of Participants With HIV Viral Load <50 Copies/mL | Plasma HIV viral load remained <50 copies/mL | Week 96 data were available for 32 completed participants | Posted | Number | percentage of participants | from Baseline to Week 96 |
|
|
|
| 5 |
| 37 |
| 23 |
| 37 |
| RIGHT FLANK/QUADRANT PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CEREBRAL ANEURYSM | Blood and lymphatic system disorders | Systematic Assessment |
|
| LEFT KIDNEY STONES | Renal and urinary disorders | Systematic Assessment |
|
| PROBABLE LUMBAR RADICULOPATHY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| HOSPITAL ADMISSION FOR MALENA AND FEVERS | Gastrointestinal disorders | Systematic Assessment |
|
| LOWER REPIRATORY TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 4 | Systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Sleep Apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
The Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the sponsor. This includes periodic information releases and announcements to the news media or a third party regarding the progress of this Study.
| 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 |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |