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The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of atazanavir in volunteers pre-treated with proton-pump inhibitors (PPIs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ritonavir-boosted Atazanavir | Active Comparator |
| |
| Ritonavir-boosted Atazanavir plus Rabeprazole | Experimental |
| |
| Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine HCl | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir-boosted Atazanavir | Drug | Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Atazanavir | The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted atazanavir alone) and tested for statistical significance. | Day 4 |
| Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Atazanavir | The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf). Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance. | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of Atazanavir | The maximum plasma concentration (Cmax) will also be measured. Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance. | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, UCSF | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D001622 | Betaine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Ritonavir-boosted Atazanavir plus Rabeprazole | Drug | Rabeprazole (20mg) PO twice daily (Days 1-3); Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 (Day 4) |
|
| Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride | Drug | Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 on Day 4 |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009861 | Onium Compounds |