Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: August 25, 2005
Last updated: April 8, 2011
Last verified: April 2011
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.

Condition Intervention Phase
HIV Infections
Drug: stavudine extended-release, lamivudine, efavirenz
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 Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen

Resource links provided by NLM:

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: 300
Study Start Date: September 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Documented HIV infection
  • 18 years of age or older and weigh at least 40 kg
  • Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
  • Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion Criteria:

  • Pregnancy, breastfeeding or plans to become pregnant during the study period
  • Any prior documented virologic failure to one or more HAART regimens
  • Active AIDS-defining opportunistic infection or disease
  • Proven or suspected acute hepatitis within 30 days prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135369

  Show 47 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00135369     History of Changes
Other Study ID Numbers: AI455-135 
Study First Received: August 25, 2005
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

ClinicalTrials.gov processed this record on May 26, 2016