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

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Atazanavir Atazanavir sulfate

U.S. FDA Resources

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
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	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. Other Name: Reyataz
Active Comparator: 2	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. Other Name: Reyataz

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	Bristol-Myers Squibb

More Information

Additional 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

No publications provided


ClinicalTrials.gov Identifier:	NCT00084253 History of Changes
Other Study ID Numbers:	AI424-089 ST
Study First Received:	June 9, 2004
Last Updated:	March 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:


HIV Treatment Naive

Additional relevant MeSH terms:


Atazanavir Lamivudine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors	HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015