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CompletedNCT00135343Updated Apr 14, 2011

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

A Phase 3 interventional study of Atazanvir/ritonavir + efavirenz and Atazanvir/ritonavir + efavirenz in HIV Infections, sponsored by Bristol-Myers Squibb. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-14.

Sponsored by Bristol-Myers Squibb · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV/AIDS
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants

Study arms

  • Experimental
    A

    Drug: Atazanvir/ritonavir + efavirenz

  • Experimental
    B

    Drug: Atazanvir/ritonavir + efavirenz

Interventions

  • DrugAtazanvir/ritonavir + efavirenz

    Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.

    Also known as: Reyataz & Sustiva

  • DrugAtazanvir/ritonavir + efavirenz

    Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.

    Also known as: Reyataz & Sustiva

06

What researchers measure

Primary outcomes

  1. Mean percent change from baseline in fasting plasma triglycerides at Week 8

Secondary outcomes

  1. Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48

  2. The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48

07

Study locations

15 sites
  • Local Institution
    San Francisco, California, United States
  • Local Institution
    Washington, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00135343
Lead sponsor
Bristol-Myers Squibb
First posted
Aug 26, 2005
Start date
Apr 2004
Primary completion
Oct 2005
Completion
Oct 2005
Last update
Apr 14, 2011

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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