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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004580
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
HIV Infections
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by Abbott:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004580

Locations
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
Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004580     History of Changes
Other Study ID Numbers: 285B, M97-765
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Drug Therapy, Combination
Nevirapine
HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
HIV Protease Inhibitors
Lopinavir
Nevirapine
Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014