Status:
COMPLETED
A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus I
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 adm...
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 1...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 26 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00082394
Start Date
April 26 2004
End Date
March 1 2006
Last Update
May 24 2017
Active Locations (45)
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1
GSK Investigational Site
Bakersfield, California, United States, 93301
2
GSK Investigational Site
Los Angeles, California, United States, 90069
3
GSK Investigational Site
Oakland, California, United States, 94609
4
GSK Investigational Site
San Francisco, California, United States, 94121