Clinical trial NCT00135343: A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
Official title: A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV/AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean percent change from baseline in fasting plasma triglycerides at Week 8
Secondary outcomes:
measure: Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
measure: The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Atlantis
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: South Miami
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Berkley
country: United States
facility: Local Institution
state: Michigan
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Clumbia
country: United States
facility: Local Institution
state: South Carolina
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Hampton
country: United States
facility: Local Institution
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: