Study of Boosted Atazanavir (ATV) Versus Non-Boosted ATV in Naive Patients - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00084253

Purpose

The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanavir/ Stavidine / Lamivudine Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine Stavudine Ritonavir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Phase IV Study of Boosted Atazanavir (ATV) Versus Non-Boosted ATV in Naive Patients

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).

Estimated Enrollment:	200
Study Start Date:	June 2004

Arms	Assigned Interventions
1: Active Comparator	Drug: Atazanavir/ Stavidine / Lamivudine Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.
2: Active Comparator	Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent
HIV RNA greater than or equal 200 copies/mL at screening
18 years old or older
Must use barrier contraception
Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications

Exclusion Criteria:

Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study
Women using oral contraceptives, pregnant or breastfeeding women
Women who have a positive pregnancy test on enrollment or before beginning to take the study medications
People who have a life expectancy of greater than 12 months
Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
Any antiretroviral therapy within 30 days prior to screening
Any prior antiretroviral therapy (greater than 30 days of NRTI and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (NNRTI) or protease inhibitor therapies)
Any of the following conditions: Cushings Syndrome, Gilbert's Syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) HIV infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, Intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease
Active alcohol or substance abuse
History or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening
Previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4
Inability to swallow capsules

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084253

Locations

United States, New Jersey
Various locations within the US
Call for Information, New Jersey, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

Study ID Numbers:	AI424-089 ST
Study First Received:	June 9, 2004
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00084253
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Ritonavir
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Lamivudine
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009