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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135343
First received: August 25, 2005
Last updated: April 7, 2011
Last verified: July 2008

August 25, 2005
April 7, 2011
April 2004
October 2005   (final data collection date for primary outcome measure)
Mean percent change from baseline in fasting plasma triglycerides at Week 8
Not Provided
Complete list of historical versions of study NCT00135343 on ClinicalTrials.gov Archive Site
  • 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
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A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: Atazanvir/ritonavir + efavirenz
    Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
    Other Name: Reyataz & Sustiva
  • Drug: Atazanvir/ritonavir + efavirenz
    Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
    Other Name: Reyataz & Sustiva
  • Experimental: A
    Intervention: Drug: Atazanvir/ritonavir + efavirenz
  • Experimental: B
    Intervention: Drug: Atazanvir/ritonavir + efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00135343
AI424-121
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Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP