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ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004582
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2000

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00004582 on ClinicalTrials.gov Archive Site
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ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects

The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).

All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/Ritonavir
  • Drug: Efavirenz
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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

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml.
  • Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry.
  • Have received more than 1 PI for at least 12 weeks each at some time in the past.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have had any active opportunistic (AIDS-related) infections within the past 30 days.
  • Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz.
  • Have received certain medications.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004582
285E, M98-957
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ViRx
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NIH AIDS Clinical Trials Information Service
August 2000

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