A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
1 other identifier
interventional
60
1 country
15
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
Started Apr 2004
Shorter than P25 for phase_3 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedApril 14, 2011
July 1, 2008
1.5 years
August 25, 2005
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean percent change from baseline in fasting plasma triglycerides at Week 8
Secondary Outcomes (2)
Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Eligibility Criteria
You may qualify if:
- Provide written informed consent
- HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
- Antiretroviral (ARV) naive prior to enrollment
- Normal plasma triglycerides ≤ 200 mg/dL
- Women of child-bearing age must use effective barrier contraception
You may not qualify if:
- Pregnancy or breast feeding
- Evidence of resistance to antiretroviral drugs
- History of elevated blood cholesterol or triglycerides
- History of diabetes
- Hypersensitivity to any component of the study drugs
- Any cholesterol or triglyceride lowering medications in the past six months
- Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months
- Imprisonment or involuntary incarceration for medical treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Local Institution
San Francisco, California, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Atlantis, Florida, United States
Local Institution
Orlando, Florida, United States
Local Institution
South Miami, Florida, United States
Local Institution
Tampa, Florida, United States
Local Institution
New Orleans, Louisiana, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Berkley, Michigan, United States
Local Institution
St Louis, Missouri, United States
Local Institution
Huntersville, North Carolina, United States
Local Institution
Clumbia, South Carolina, United States
Local Institution
Austin, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Hampton, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
April 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
April 14, 2011
Record last verified: 2008-07