Clinical trial NCT00135395: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV/AIDS
Treatment Experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Hobson City
country: United States
facility: Local Institution
state: Alabama
city: Montgomery
country: United States
facility: Local Institution
state: Alabama
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Bakersfield
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: San Mateo
country: United States
facility: Local Institution
state: California
city: Tarzana
country: United States
facility: Local Institution
state: California
city: West Hollywood
country: United States
facility: Local Institution
state: California
city: Norwalk
country: United States
facility: Local Institution
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Atlantis
country: United States
facility: Local Institution
state: Florida
city: Fort Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Miami Beach
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: North Miami
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Plantation
country: United States
facility: Local Institution
state: Florida
city: Safety Harbor
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Decatur
country: United States
facility: Local Institution
state: Georgia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Berkley
country: United States
facility: Local Institution
state: Michigan
city: Jackson
country: United States
facility: Local Institution
state: Mississippi
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: East Orange
country: United States
facility: Local Institution
state: New Jersey
city: Hillsborough
country: United States
facility: Local Institution
state: New Jersey
city: Jersey City
country: United States
facility: Local Institution
state: New Jersey
city: Brooklyn
country: United States
facility: Local Institution
state: New York
city: Mt. Vernon
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Valhalla
country: United States
facility: Local Institution
state: New York
city: Greenville
country: United States
facility: Local Institution
state: North Carolina
city: Huntersville
country: United States
facility: Local Institution
state: North Carolina
city: Winston Salem
country: United States
facility: Local Institution
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Galveston
country: United States
facility: Local Institution
state: Texas
city: Harlingen
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Hampton
country: United States
facility: Local Institution
state: Virginia
city: Santruce
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: