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

August 25, 2005
January 27, 2010
June 2002
October 2005   (final data collection date for primary outcome measure)
Efficacy at week 48
Not Provided
Complete list of historical versions of study NCT00135382 on ClinicalTrials.gov Archive Site
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
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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
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Videx EC
  • Drug: Epivir
  • Drug: Sustiva
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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
254
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00135382
AI266-406
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Bristol-Myers Squibb
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Not Provided
Bristol-Myers Squibb
January 2010

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