ATV/Ritonavir Nevirapine Interaction (USPAC)

Study Overview
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Brief Summary
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Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.

Official Title
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Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Nevirapine
* Drug: Nevirapine + Atazanavir/Ritonavir
* Drug: Nevirapine + Atazanavir/Ritonavir
* Drug: Atazanavir + Ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent form For Cohort 1, HIV-infected subjects receiving nevirapine 200 mg twice-daily and 2 to 3 NRTIs for at least 6 weeks For Cohort 2, HIV-infected subjects receiving atazanavir 300 mg and ritonavir 100 mg once-daily and 2 to 3 NRTIs for at least 6 weeks Have had 2 measurements of plasma HIV RNA of <400 copies/mL. The first test being 6 to 16 weeks prior and the second being within 3 weeks prior to Day 1 Have CD4 cell count >=200 cells/mm3 Body Mass Index of 18 to 35 kg/m2. Men and women, ages 18 to 55. Exclusion Criteria: Women who are pregnant or breastfeeding Presence of a newly diagnosed HIV-related opportunistic infection or CD4 cell count <200 cell/mm3 within the previous 6 months. Any significant acute or chronic medical illness, unless stable or controlled by a non-prohibited medication. History of virologic failure on an antiretroviral regimen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Nevirapine<br>* Tablets, Oral, 200 mg, Twice daily, 3 days.<br>|
| Experimental: A2<br> | Drug: Nevirapine + Atazanavir/Ritonavir<br>* Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.<br>* Other names: Reyataz;|
| Experimental: A3<br> | Drug: Nevirapine + Atazanavir/Ritonavir<br>* Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.<br>* Other names: Reyataz;|
| No Intervention: B1<br> | Drug: Atazanavir + Ritonavir<br>* Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.<br>* Other names: Reyataz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady state PK of 2 atazanavir/ritonavir&nevirapine regimens relative to historic data of atazanavir 400mg in HIV-inf subj;Safety & tolerability of co-admin of atazanavir,ritonavir,&nevirapine in the presence of 2to3 nucleoside rev. transcriptase inhibi |  |  |