A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
2 other identifiers
interventional
N/A
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 20, 2009
February 1, 2009
November 2, 1999
February 19, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (10)
Pacific Oaks Research
Beverly Hills, California, 90211, United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
Chicago, Illinois, 60612, United States
Univ North Carolina at Chapel Hill / Dept of Medicine
Chapel Hill, North Carolina, 27599, United States
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, 27710, United States
Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
Cincinnati, Ohio, 452670405, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 152132582, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
February 20, 2009
Record last verified: 2009-02