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

Completed · Phase 4

Conditions studied: Infection, Human Immunodeficiency Virus I, HIV Infection

In brief

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.

Key facts

Study ID

NCT00082394

Run by

GlaxoSmithKline

Starts

2004-04-26

Expected to finish

2006-03-01

Last updated by the study team

2017-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Fort Collins, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, 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 — Miami, Florida, United States
• GSK Investigational Site — Miami Beach, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Louisville, Kentucky, 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 — St Louis, Missouri, United States
• GSK Investigational Site — East Orange, New Jersey, United States
• GSK Investigational Site — Hillsborough, New Jersey, United States
• GSK Investigational Site — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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