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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135382
First received: August 25, 2005
Last updated: January 27, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Videx EC
Drug: Epivir
Drug: Sustiva
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Efficacy at week 48

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 254
Study Start Date: June 2002
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135382

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00135382     History of Changes
Other Study ID Numbers: AI266-406
Study First Received: August 25, 2005
Last Updated: January 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS

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
Protease Inhibitors
 Lamivudine
Efavirenz
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 17, 2013