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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanvir/ritonavir + efavirenz (Drug); Atazanvir/ritonavir + efavirenz (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

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

Primary outcome: Mean percent change from baseline in fasting plasma triglycerides at Week 8

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: April 2004
Last updated: April 7, 2011

Page last updated: August 23, 2015

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