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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004580
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 20, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lopinavir/Ritonavir Drug: Nevirapine Phase 1

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


- 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:


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:


  • 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:


  • 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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004580

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United States, California
Pacific Oaks Research
Beverly Hills, California, United States, 90211
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States, 94110
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
Chicago, Illinois, United States, 60612
United States, North Carolina
Univ North Carolina at Chapel Hill / Dept of Medicine
Chapel Hill, North Carolina, United States, 27599
Duke Univ Med Ctr / Infectious Disease Clinic
Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 152132582
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
Sponsors and Collaborators
Layout table for additonal information Identifier: NCT00004580    
Other Study ID Numbers: 285B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009
Keywords provided by Abbott:
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers