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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00004580

Run by

Abbott

Last updated by the study team

2009-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Excluded:
• Active substance abuse, alcohol abuse, psychiatric illness.
• Presumption, by investigator, of poor compliance to regimen.

Where it is running

• Pacific Oaks Research — Beverly Hills, California, United States
• San Francisco Gen Hosp / UCSF AIDS Program — San Francisco, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise — Chicago, Illinois, United States
• Univ North Carolina at Chapel Hill / Dept of Medicine — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr / Infectious Disease Clinic — Durham, North Carolina, United States
• Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405 — Cincinnati, Ohio, United States
• Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Infectious Disease Physicians Inc — Annandale, Virginia, United States

Full record on ClinicalTrials.gov

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