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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.

Sponsored by: ViRx
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00004582
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/Ritonavir
Drug: Efavirenz
Phase II

MedlinePlus related topics:   AIDS   

Drug Information available for:   Efavirenz    Ritonavir    Lopinavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004582

Locations
United States, California
ViRx Inc    
      San Francisco, California, United States, 94103

Sponsors and Collaborators
ViRx
  More Information


Study ID Numbers:   285E, M98-957
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004582
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV Protease Inhibitors  
Ritonavir  
Reverse Transcriptase Inhibitors  
Anti-HIV Agents  
Viral Load
ABT 378
efavirenz

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008




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