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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: Trizivir (Drug); atazanavir (Drug); Combivir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, PharmD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: See Detailed Description

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: % 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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Bakersfield, California 93301, United States

GSK Investigational Site, Los Angeles, California 90069, United States

GSK Investigational Site, Oakland, California 94609, United States

GSK Investigational Site, San Francisco, California 94121, United States

GSK Investigational Site, Fort Collins, Colorado 80528, United States

GSK Investigational Site, Washington, District of Columbia 20007, United States

GSK Investigational Site, Fort Lauderdale, Florida 33145, United States

GSK Investigational Site, Fort Lauderdale, Florida 33306, United States

GSK Investigational Site, Fort Lauderdale, Florida 33308, United States

GSK Investigational Site, Fort Myers, Florida 33901, United States

GSK Investigational Site, Miami Beach, Florida 33140, United States

GSK Investigational Site, Miami, Florida 33136, United States

GSK Investigational Site, Orlando, Florida 32804, United States

GSK Investigational Site, Atlanta, Georgia 30339, United States

GSK Investigational Site, Decatur, Georgia 30033, United States

GSK Investigational Site, Chicago, Illinois 60637, United States

GSK Investigational Site, Guadalajara, Jalisco 44340, Mexico

GSK Investigational Site, Wichita, Kansas 67214, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, New Orleans, Louisiana 70115, United States

GSK Investigational Site, New Orleans, Louisiana 70127-0800, United States

GSK Investigational Site, New Orleans, Louisiana 70112, United States

GSK Investigational Site, St. Louis, Missouri 63139, United States

GSK Investigational Site, East Orange, New Jersey 7017, United States

GSK Investigational Site, Hillsborough, New Jersey 08876, United States

GSK Investigational Site, Newark, New Jersey 7102, United States

GSK Investigational Site, Voorhees, New Jersey 08043, United States

GSK Investigational Site, Mount Vernon, New York 10550, United States

GSK Investigational Site, Valhalla, New York 10595, United States

GSK Investigational Site, Charlotte, North Carolina 28209, United States

GSK Investigational Site, Greenville, North Carolina 27858-4354, United States

GSK Investigational Site, Monterrey, Nuevo León 64460, Mexico

GSK Investigational Site, Akron, Ohio 44304, United States

GSK Investigational Site, Portland, Oregon 97219, United States

GSK Investigational Site, Allentown, Pennsylvania 18102, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, West Reading, Pennsylvania 19611, United States

GSK Investigational Site, Columbia, South Carolina 29203, United States

GSK Investigational Site, Greenville, South Carolina 29605, United States

GSK Investigational Site, Austin, Texas 78705, United States

GSK Investigational Site, Dallas, Texas 75246, United States

GSK Investigational Site, Dallas, Texas 75208, United States

GSK Investigational Site, Harlingen, Texas 78550, United States

GSK Investigational Site, Houston, Texas 77027, United States

GSK Investigational Site, Hampton, Virginia 23666, United States

Additional Information

Starting date: April 2004
Last updated: September 29, 2010

Page last updated: August 23, 2015

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