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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atazanvir/ritonavir + efavirenz

Drug

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

Other names: Reyataz & Sustiva

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Aug 26, 2005
Registry last updated: Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed