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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014924-42 | EudraCT Number |
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This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects currently attending for HIV care at St. Mary's Hospital, London will be eligible.
The study will describe the steady state pharmacokinetic parameters and short term safety of maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.
Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving antiretroviral therapy comprising:
On day 1, subjects will modify their current antiretroviral therapy to the following:
On day 11, subjects will modify their current antiretroviral therapy to the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truvada, Darunavir/r and Maraviroc | Experimental | Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | Maraviroc 150 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day | On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured . | 10 day, 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests | Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes. | 35 days |
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Inclusion Criteria:
Exclusion Criteria:
male only
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| Name | Affiliation | Role |
|---|---|---|
| Alan Winston, MB BH | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23364475 | Result | Mora-Peris B, Croucher A, Else LJ, Vera JH, Khoo S, Scullard G, Back D, Winston A. Pharmacokinetic profile and safety of 150 mg of maraviroc dosed with 800/100 mg of darunavir/ritonavir all once daily, with and without nucleoside analogues, in HIV-infected subjects. J Antimicrob Chemother. 2013 Jun;68(6):1348-53. doi: 10.1093/jac/dkt006. Epub 2013 Jan 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Truvada, Darunavir/r and Maraviroc | Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| With Tenofovir/Emtricitabine (10 Days) |
|
| |||||||||||||||||||||
| Without Tenofovir/Emtricitabine (11 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Truvada, Darunavir/r and Maraviroc | Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day | On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured . | Posted | Mean | 95% Confidence Interval | ratio | 10 day, 20 days |
|
|
1 year
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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 | Truvada, Darunavir/r and Maraviroc | Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Winston | Imperial College London | +442033121603 | 21603 | a.winston@imperial.ac.uk |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000069454 | Darunavir |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Truvada |
| Drug |
daily until 10. day then stop |
|
| Darunavir | Drug | daily until 10. day then stop |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests | Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes. | No data reported | Posted | Count of Participants | Participants | 35 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| 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 |