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NCT00082394 Clinical Trial

A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00082394
Other study ID # 100327
Secondary ID
Status Completed
Phase Phase 4
First received May 6, 2004
Last updated May 23, 2017
Start date April 26, 2004
Est. completion date March 1, 2006

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 1, 2006
Est. primary completion date March 1, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Trizivir

• atazanavir

• Combivir

Locations
Country Name City State
Mexico GSK Investigational Site Guadalajara Jalisco
Mexico GSK Investigational Site Monterrey Nuevo León
United States GSK Investigational Site Akron Ohio
United States GSK Investigational Site Allentown Pennsylvania
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Bakersfield California
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Columbia South Carolina
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Decatur Georgia
United States GSK Investigational Site East Orange New Jersey
United States GSK Investigational Site Fort Collins Colorado
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Greenville North Carolina
United States GSK Investigational Site Greenville South Carolina
United States GSK Investigational Site Hampton Virginia
United States GSK Investigational Site Harlingen Texas
United States GSK Investigational Site Hillsborough New Jersey
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Louisville Kentucky
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Beach Florida
United States GSK Investigational Site Mount Vernon New York
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site Newark New Jersey
United States GSK Investigational Site Oakland California
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site Valhalla New York
United States GSK Investigational Site Voorhees New Jersey
United States GSK Investigational Site Washington, D.C. District of Columbia
United States GSK Investigational Site West Reading Pennsylvania
United States GSK Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 48 Weeks
Secondary % 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 48 Weeks
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