Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2005-10-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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A1
Nevirapine
Tablets, Oral, 200 mg, Twice daily, 3 days.
A2
Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
A3
Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
B1
Atazanavir + Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Interventions
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Nevirapine
Tablets, Oral, 200 mg, Twice daily, 3 days.
Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.
Nevirapine + Atazanavir/Ritonavir
Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.
Atazanavir + Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Pomona, California, United States
Local Institution
Seattle, Washington, United States
Local Institution
London, Greater London, United Kingdom
Countries
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Other Identifiers
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AI424-137
Identifier Type: -
Identifier Source: org_study_id
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