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A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atazanavir+ritonavir
Lopinavir+ritonavir
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/AIDS, Treatment Experienced

Eligibility Criteria

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

Inclusion Criteria: Patients ≥ 18 years of age infected with HIV Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3 Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available) The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL) Exclusion Criteria: Pregnancy or breastfeeding Reported virologic failure to two or more antiretroviral regimens Active AIDS-defined opportunistic infection or disease Proven or suspected acute hepatitis within 30 days prior to study entry

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12

Secondary Outcome Measures

Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.

Full Information

First Posted
August 25, 2005
Last Updated
February 3, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00135395
Brief Title
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
Official Title
A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atazanavir+ritonavir
Other Intervention Name(s)
Reyataz
Intervention Description
Capsules, Oral, 300mg/100mg, once daily, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Lopinavir+ritonavir
Intervention Description
Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.
Primary Outcome Measure Information:
Title
Co-Primary Outcomes in this study 1)Viral load reduction from baseline through Week 24 2)Change in lipids from baseline at Week 12
Secondary Outcome Measure Information:
Title
Viral load reduction from baseline at Weeks 48,72,96;Subjects with HIV RNA<50 and <400 c/mL at Weeks 24,48,72 & 96;Patterns of resistance;Safety and tolerability through Week 96 including fasting lipid values;Adherence at Weeks 4,12,24,48,72 & 96.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years of age infected with HIV Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3 Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available) The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL) Exclusion Criteria: Pregnancy or breastfeeding Reported virologic failure to two or more antiretroviral regimens Active AIDS-defined opportunistic infection or disease Proven or suspected acute hepatitis within 30 days prior to study entry
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
Local Institution
City
Hobson City
State/Province
Alabama
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United States
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Local Institution
City
Montgomery
State/Province
Alabama
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United States
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Local Institution
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Local Institution
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Mateo
State/Province
California
Country
United States
Facility Name
Local Institution
City
Tarzana
State/Province
California
Country
United States
Facility Name
Local Institution
City
West Hollywood
State/Province
California
Country
United States
Facility Name
Local Institution
City
Norwalk
State/Province
Connecticut
Country
United States
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Local Institution
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Washington
State/Province
District of Columbia
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United States
Facility Name
Local Institution
City
Atlantis
State/Province
Florida
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United States
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Local Institution
City
Fort Lauderdale
State/Province
Florida
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United States
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City
Jacksonville
State/Province
Florida
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United States
Facility Name
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City
Miami Beach
State/Province
Florida
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United States
Facility Name
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Miami
State/Province
Florida
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United States
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City
North Miami
State/Province
Florida
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United States
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Orlando
State/Province
Florida
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United States
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Plantation
State/Province
Florida
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United States
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Safety Harbor
State/Province
Florida
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United States
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Tampa
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Florida
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United States
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Atlanta
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Georgia
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United States
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Decatur
State/Province
Georgia
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United States
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Chicago
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Illinois
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United States
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Indianapolis
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Indiana
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United States
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Local Institution
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Louisville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
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New Orleans
State/Province
Louisiana
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United States
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Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
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Local Institution
City
Springfield
State/Province
Massachusetts
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United States
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Local Institution
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Berkley
State/Province
Michigan
Country
United States
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Local Institution
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Jackson
State/Province
Mississippi
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United States
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St. Louis
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Missouri
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United States
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Las Vegas
State/Province
Nevada
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United States
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East Orange
State/Province
New Jersey
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United States
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Hillsborough
State/Province
New Jersey
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United States
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Jersey City
State/Province
New Jersey
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United States
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Local Institution
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Brooklyn
State/Province
New York
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United States
Facility Name
Local Institution
City
Mt. Vernon
State/Province
New York
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
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United States
Facility Name
Local Institution
City
Valhalla
State/Province
New York
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United States
Facility Name
Local Institution
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Greenville
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
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Huntersville
State/Province
North Carolina
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United States
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Local Institution
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Winston Salem
State/Province
North Carolina
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United States
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Oklahoma City
State/Province
Oklahoma
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United States
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Philadelphia
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Pennsylvania
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United States
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Columbia
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South Carolina
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United States
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Dallas
State/Province
Texas
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United States
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Galveston
State/Province
Texas
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United States
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Local Institution
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Harlingen
State/Province
Texas
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United States
Facility Name
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Houston
State/Province
Texas
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United States
Facility Name
Local Institution
City
Hampton
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Santruce
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

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