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This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maalox Plus extra | Active Comparator | Subjects will receive doses of raltegravir 400 mg and maalox plus extra |
|
| Multivitamin | Active Comparator | Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet |
|
| Sodium bicarbonate | Active Comparator | Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamins | Dietary Supplement |
| ||
| Sodium bicarbonate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in raltegravir Area under the curve (AUC)0-12h | The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin | Day 1, 6, 11, 16 and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of gastrointestinal pH | Correlation between gastric pH and raltegravir pharmacokinetics | Day 1, 6, 11, 16 and 21 |
| Number of adverse events | Day 1 up to end of study Day 27 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saye Khoo, Prof | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 26, 2018 | |
| Reset | Oct 19, 2018 | |
| Release | Oct 30, 2018 | |
| Reset | Mar 1, 2019 | |
| Release | Mar 14, 2019 | |
| Reset | Jun 17, 2019 | |
| Release | May 1, 2026 | |
| Reset | May 27, 2026 | |
| Release | May 28, 2026 | |
| Reset | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 26, 2018 | Oct 19, 2018 | |||
| Oct 30, 2018 |
| ID | Term |
|---|---|
| C067316 | Geritol |
| D017693 | Sodium Bicarbonate |
| C013591 | aluminum hydroxide, magnesium hydroxide, drug combination |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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|
| Maalox Plus extra | Drug |
|
| Raltegravir 400 mg | Drug |
|
| Mar 1, 2019 |
| Mar 14, 2019 | Jun 17, 2019 |
| May 1, 2026 | May 27, 2026 |
| May 28, 2026 | Jun 23, 2026 |
| Jun 25, 2026 |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |