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

November 2, 1999
February 19, 2009
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Complete list of historical versions of study NCT00004580 on ClinicalTrials.gov Archive Site
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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.

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Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/Ritonavir
  • Drug: Nevirapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004580
285B, M97-765
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Abbott
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Abbott
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP