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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00082394 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Trizivir Drug: atazanavir Drug: Combivir |
Phase IV |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Abacavir Abacavir sulfate Lamivudine Atazanavir sulfate BMS 232632 Combivir Trizivir |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 280 |
Study Start Date: | May 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Show 57 Study Locations |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, PharmD | GlaxoSmithKline |
Study ID Numbers: | 100327 |
First Received: | May 6, 2004 |
Last Updated: | August 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00082394 |
Health Authority: | United States: Food and Drug Administration |
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