A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.
1 other identifier
interventional
345
1 country
58
Brief Summary
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2003
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 4, 2003
CompletedFirst Posted
Study publicly available on registry
February 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedOctober 4, 2010
October 1, 2010
1.7 years
February 4, 2003
October 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Viral load response at 48 weeks
48 weeks
Secondary Outcomes (1)
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics
48 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Participants must be able to provide informed consent.
- Have documented HIV-1 infection.
- Have not received more than 14 days of prior treatment with antiretroviral drugs.
- Meet laboratory test criteria.
- Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
- Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.
You may not qualify if:
- Enrolled in other HIV treatment studies.
- Pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (58)
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
San Francisco, California, 94115-1931, United States
GSK Investigational Site
Denver, Colorado, 80205, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
Fort Collins, Colorado, 80528, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20007-2113, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20009, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20036, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33145, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Fort Myers, Florida, 33901, United States
GSK Investigational Site
Jacksonville, Florida, 32206, United States
GSK Investigational Site
Miami, Florida, 33133, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Tampa, Florida, 33602, United States
GSK Investigational Site
Vero Beach, Florida, 32960, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Atlanta, Georgia, 30339, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Chicago, Illinois, 60657, United States
GSK Investigational Site
Indianapolis, Indiana, 46202 - 5124, United States
GSK Investigational Site
Wichita, Kansas, 67214, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
New Orleans, Louisiana, 70127-0800, United States
GSK Investigational Site
Minneapolis, Minnesota, 55404, United States
GSK Investigational Site
Hillsborough, New Jersey, 08844, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131-0001, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Buffalo, New York, 14215, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
New York, New York, 10014, United States
GSK Investigational Site
Stony Brook, New York, 11794, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Cincinnati, Ohio, 45267-0405, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Portland, Oregon, 97219, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19102, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Reading, Pennsylvania, 19601, United States
GSK Investigational Site
Providence, Rhode Island, 02903, United States
GSK Investigational Site
Columbia, South Carolina, 29206-4713, United States
GSK Investigational Site
Dallas, Texas, 75208, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Tyler, Texas, 75708, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Lynchburg, Virginia, 24501, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Green Bay, Wisconsin, 54301, United States
Related Publications (1)
Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier E. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8. doi: 10.1086/595296.
PMID: 19032103DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 4, 2003
First Posted
February 5, 2003
Study Start
February 1, 2003
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
October 4, 2010
Record last verified: 2010-10