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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Atazanavir Sulfate; Lamivudine, zidovudine drug combination

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.