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Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

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.
ClinicalTrials.gov Identifier: NCT00135382
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : February 17, 2010
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Videx EC Drug: Epivir Drug: Sustiva Phase 3

Detailed Description:
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
Study Start Date : June 2002
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Efficacy at week 48

Secondary Outcome Measures :
  1. Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Documented HIV infection
  • ≥ 18 years of age and weight at least 40kg
  • Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
  • Patients receiving a PI and ≥ 2 NRTIs

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
  • Active AIDS-defining opportunistic infection or disease
  • Proven or suspected acute hepatitis within 30 days prior to study entry
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00135382

  Show 48 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00135382     History of Changes
Other Study ID Numbers: AI266-406
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: January 2010

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents