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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atazanavir/ Stavidine / Lamivudine
Atazanavir-Ritonavir/ Stavidine / Lamivudine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Various locations within the US

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
June 9, 2004
Last Updated
March 4, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00084253
Brief Title
Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
Official Title
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atazanavir/ Stavidine / Lamivudine
Other Intervention Name(s)
Reyataz
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atazanavir-Ritonavir/ Stavidine / Lamivudine
Other Intervention Name(s)
Reyataz
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Various locations within the US
City
Call for Information
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

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

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