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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: Atazanvir/ritonavir + efavirenz

• Registration Number: NCT00135343
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-07
• Disposition First Submitted: 2010-01-27
• Disposition First Submitted QC: 2010-01-27
• Disposition First Posted: 2010-02-15
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Atazanvir/ritonavir + efavirenz	-
B	Atazanvir/ritonavir + efavirenz	-

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline in fasting plasma triglycerides at Week 8

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Hampton, Virginia, United States