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
Data Collection
Blood-Borne Infections+15
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: April 26, 2004
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 45 locations
GSK Investigational Site
Los Angeles, United StatesGSK Investigational Site
Oakland, United StatesGSK Investigational Site
San Francisco, United States