- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00084253
Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
March 4, 2010 updated by: Bristol-Myers Squibb
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Call for Information, New Jersey, United States
- Various locations within the US
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
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 Names:
|
Active Comparator: 1
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
June 9, 2004
First Submitted That Met QC Criteria
June 10, 2004
First Posted (Estimate)
June 11, 2004
Study Record Updates
Last Update Posted (Estimate)
March 5, 2010
Last Update Submitted That Met QC Criteria
March 4, 2010
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Lamivudine
- Atazanavir Sulfate
Other Study ID Numbers
- AI424-089 ST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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