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

HIV Infections Clinical Trial

Official title:

Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004580
• Other study ID #: 285B
• Secondary ID: M97-765
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: February 19, 2009

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lopinavir/Ritonavir

• Nevirapine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States,