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ATV/Ritonavir Nevirapine Interaction (USPAC)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Nevirapine (Drug); Nevirapine + Atazanavir/Ritonavir (Drug); Nevirapine + Atazanavir/Ritonavir (Drug); Atazanavir + Ritonavir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: 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: 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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Local Institution, Pomona, California, United States

Local Institution, London, Greater London, United Kingdom

Local Institution, Seattle, Washington, United States

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: October 2005
Last updated: April 7, 2011

Page last updated: August 23, 2015

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