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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Nevirapine; Drug: Lopinavir/Ritonavir

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Pacific Oaks Research
    • San Francisco, California, United States, 94110
      • San Francisco Gen Hosp / UCSF AIDS Program
  • Colorado
    • Denver, Colorado, United States, 80262
      • Univ of Colorado Health Sciences Ctr
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Univ North Carolina at Chapel Hill / Dept of Medicine
    • Durham, North Carolina, United States, 27710
      • Duke Univ Med Ctr / Infectious Disease Clinic
  • Ohio
    • Cincinnati, Ohio, United States, 452670405
      • Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 152132582
      • Univ of Pittsburgh
  • Virginia
    • Annandale, Virginia, United States, 22203
      • Infectious Disease Physicians Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): February 20, 2009
• Last Update Submitted That Met QC Criteria: February 19, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Nevirapine; Reverse Transcriptase Inhibitors; HIV Protease Inhibitors; Ritonavir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; HIV Protease Inhibitors; Viral Protease Inhibitors; Nevirapine; Ritonavir; Lopinavir
• Other Study ID Numbers: 285B; M97-765