ATV/Ritonavir Nevirapine Interaction (USPAC)

NCT00162149 | Completed Phase 1

• 1 other identifier: AI424-137
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

A1

NO INTERVENTION

Drug: Nevirapine

A2

EXPERIMENTAL

Drug: Nevirapine + Atazanavir/Ritonavir

A3

EXPERIMENTAL

Drug: Nevirapine + Atazanavir/Ritonavir

B1

NO INTERVENTION

Drug: Atazanavir + Ritonavir

Interventions

Nevirapine DRUG

Tablets, Oral, 200 mg, Twice daily, 3 days.

A1

Nevirapine + Atazanavir/Ritonavir DRUG

Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.

Also known as: Reyataz

A2

Atazanavir + Ritonavir DRUG

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

Also known as: Reyataz

B1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution

Pomona, California, United States

Location

Local Institution

Seattle, Washington, United States

Location

Local Institution

London, Greater London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine; Atazanavir Sulfate; Ritonavir; atazanavir, ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 8, 2011

Record last verified: 2008-06

Locations

US (2); GB (1)