Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients

Study Overview
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Brief Summary
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The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.

Official Title
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Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Atazanavir/Ritonavir
* Drug: Atazanavir/Ritonavir + Famotidine
* Drug: Atazanavir/Ritonavir + Famotidine
* Drug: Atazanavir/Ritonavir
* Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
* Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m² Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA <400 copies/mL and have CD4 count >200 cells/mm³

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A1<br> | Drug: Atazanavir/Ritonavir<br>* Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.<br>* Other names: Reyataz;|
| Experimental: A2<br> | Drug: Atazanavir/Ritonavir + Famotidine<br>* Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.<br>* Other names: Reyataz;|
| Experimental: A3<br> | Drug: Atazanavir/Ritonavir + Famotidine<br>* Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.<br>* Other names: Reyataz;|
| No Intervention: B1<br> | Drug: Atazanavir/Ritonavir<br>* Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.<br>* Other names: Reyataz;|
| Experimental: B2<br> | Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine<br>* Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.<br>* Other names: Reyataz;|
| Experimental: B3<br> | Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine<br>* Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.<br>* Other names: Reyataz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atazanavir plasma drug concentrations |  | on days 10, 11, 17, 18, 24 and 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ritonavir plasma drug concentrations |  | on days 10, 11, 17, 18, 24 and 25 | 
| Safety measures: Physical examinations |  |  | 
| ECGs |  | entry and discharge | 
| laboratory tests including, liver and renal function |  | entry, discharge and days 11, 18 | 
| CD4 count |  | discharge | 
| HIV viral load |  | entry and discharge |