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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.
This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Other | Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction | A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues. | baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol Baseline and After 24 Weeks | baseline to week 24 | |
| Triglycerides Baseline and After 24 Weeks | baseline to week 24 | |
| High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Greil, MD | PMU Salzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PMU Salzburg | Salzburg | 5020 | Austria | |||
| AKH Wien |
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11 patients were enrolled at 3 sites in Austria. First patient in was 15.05.2014; last patient in was 23.06.2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir | Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir | Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir |
| 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 | Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction | A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues. | all patients | Posted | Number | 95% Confidence Interval | percentage of participants | baseline to week 12 |
|
19 months
All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study 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 | Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public contact Daniela Wolkersdorfer | AGMT | 00436626404411 | d.wolkersdorfer@agmt.at |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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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| baseline to week 24 |
| Vienna |
| 1090 |
| Austria |
| Ottto Wagner Spital | Vienna | 1140 | Austria |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Total Cholesterol Baseline and After 24 Weeks | Posted | Mean | Standard Deviation | mg/dl | baseline to week 24 |
|
|
|
| Secondary | Triglycerides Baseline and After 24 Weeks | Posted | Mean | Standard Deviation | mg/dl | baseline to week 24 |
|
|
|
| Secondary | High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks | Posted | Mean | Standard Deviation | mg/dl | baseline to week 24 |
|
|
|
| 1 |
| 11 |
| 5 |
| 11 |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
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| 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 |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |