A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

HIV Infections Clinical Trial

Official title:

A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135343
• Other study ID #: AI424-121
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: April 7, 2011
• Start date: April 2004
• Est. completion date: October 2005

Study information

• Verified date: July 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
• Atazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.

Locations

Country	Name	City	State
United States	Local Institution	Atlantis	Florida
United States	Local Institution	Austin	Texas
United States	Local Institution	Berkley	Michigan
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Clumbia	South Carolina
United States	Local Institution	Dallas	Texas
United States	Local Institution	Hampton	Virginia
United States	Local Institution	Huntersville	North Carolina
United States	Local Institution	New Orleans	Louisiana
United States	Local Institution	Orlando	Florida
United States	Local Institution	San Francisco	California
United States	Local Institution	South Miami	Florida
United States	Local Institution	St. Louis	Missouri
United States	Local Institution	Tampa	Florida
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change from baseline in fasting plasma triglycerides at Week 8
Secondary	Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
Secondary	The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm