Clinical trial NCT00082394: A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV
Official title: A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects Over 48 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Keywords: safety
drug efficacy
TRIZIVIR
tolerability
COMBIVIR
HIV
atazanavir
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-05-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

Detailed description: A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) BID vs Combivir (lamivudine 150mg and zidovudine 300mg) BID plus atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks

Eligibility criteria: Inclusion criteria:

* Adults with documented HIV-1 infection.
* Past use of HIV drugs must have been less than 15 days.
* Plasma HIV-1 RNA between 500 and 20,000 copies/mL.
* CD4+ cell count greater than 100 cells/mm3.
* Willing/able to provide written informed consent.

Exclusion criteria:

* Have AIDS at screening.
* Pregnant or breastfeeding.
* Underlying medical conditions considered to be significant for this protocol.
* Participating in other investigational drug trials.
* In the opinion of the investigator, would be unable to complete 48 weeks of dosing.

Primary outcomes:
measure: The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint.
timeFrame: 48 Weeks
Secondary outcomes:
measure: % patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: East Orange
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Hillsborough
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Mount Vernon
country: United States
facility: GSK Investigational Site
state: New York
city: Valhalla
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Harlingen
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kumar PN, Salvato P, LaMarca A, DeJesus E, Patel P, McClernon D, Florance A, Shaefer MS. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther. 2009 Apr 9;6:3. doi: 10.1186/1742-6405-6-3.