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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats.
Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Raltegravir plus truvada | Active Comparator | Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks |
|
| 2. ritonavir boosted darunavir plus truvada | Active Comparator | Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| raltegravir plus truvada | Drug | raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks | Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety | Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio | 24 weeks |
| Other metabolic parameters | Fasting metabolic parameters will be assessed. Study staff and participants will be blinded to the results fo these tests until completion of the study or parameters become sginificantly abnormal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Carr, Professor | St Vincent's Hospital - Sydney, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia | ||
| St Vincent Hospital, Clinical Research Program |
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| Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) | Drug | Darunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks |
|
|
| 24 weeks |
| Arterial stiffness | 24 weeks |
| Sydney |
| New South Wales |
| 2010 |
| Australia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068698 | Tenofovir |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D013844 | Thiazoles |
| D001393 | Azoles |
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