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

Condition(s) targeted: HIV Infections

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

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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.

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Starting date: May 2004
Last updated: August 23, 2007