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A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Nevirapine
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks. Patients must have: - HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening. Prior Medication: Allowed: Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors. Exclusion Criteria Concurrent Medication: Excluded: Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine. Over-the-counter medicine or alcohol, without knowledge or permission of the investigator. Patients with the following prior conditions are excluded: Evidence of acute illness determined by vital signs, physical examination, or laboratory results. Clinically significant abnormal ECG results. Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study. Prior Medication: Excluded: Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing. Treatment with a non-nucleoside reverse transcriptase inhibitor. Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen. Treatment with more than one protease inhibitor concurrently. Risk Behavior: Excluded: Active substance abuse, alcohol abuse, psychiatric illness. Presumption, by investigator, of poor compliance to regimen.

Sites / Locations

  • Pacific Oaks Research
  • San Francisco Gen Hosp / UCSF AIDS Program
  • Univ of Colorado Health Sciences Ctr
  • AIDS Research Consortium of Atlanta
  • Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
  • Univ North Carolina at Chapel Hill / Dept of Medicine
  • Duke Univ Med Ctr / Infectious Disease Clinic
  • Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
  • Univ of Pittsburgh
  • Infectious Disease Physicians Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 19, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00004580
Brief Title
A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
Official Title
Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nevirapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks. Patients must have: - HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening. Prior Medication: Allowed: Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors. Exclusion Criteria Concurrent Medication: Excluded: Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine. Over-the-counter medicine or alcohol, without knowledge or permission of the investigator. Patients with the following prior conditions are excluded: Evidence of acute illness determined by vital signs, physical examination, or laboratory results. Clinically significant abnormal ECG results. Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study. Prior Medication: Excluded: Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing. Treatment with a non-nucleoside reverse transcriptase inhibitor. Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen. Treatment with more than one protease inhibitor concurrently. Risk Behavior: Excluded: Active substance abuse, alcohol abuse, psychiatric illness. Presumption, by investigator, of poor compliance to regimen.
Facility Information:
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
San Francisco Gen Hosp / UCSF AIDS Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ North Carolina at Chapel Hill / Dept of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke Univ Med Ctr / Infectious Disease Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
152132582
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States

12. IPD Sharing Statement

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A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors

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