A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
Public ClinicalTrials.gov record NCT00053638. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00053638
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 345 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2003 (Type not available)
- Primary completion
- Oct 2004 (Actual)
- Completion
- Oct 2004 (Actual)
- Last update posted
- Oct 4, 2010
2003 – 2004
United States locations
- U.S. sites
- 58
- U.S. states
- 24
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85006 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | San Francisco | California | 94115-1931 | — |
| GSK Investigational Site | Denver | Colorado | 80205 | — |
| GSK Investigational Site | Denver | Colorado | 80220 | — |
| GSK Investigational Site | Fort Collins | Colorado | 80528 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007-2113 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20036 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33145 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| GSK Investigational Site | Fort Myers | Florida | 33901 | — |
| GSK Investigational Site | Jacksonville | Florida | 32206 | — |
| GSK Investigational Site | Miami | Florida | 33133 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | North Miami | Florida | 33161 | — |
| GSK Investigational Site | Orlando | Florida | 32804 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Tampa | Florida | 33602 | — |
| GSK Investigational Site | Vero Beach | Florida | 32960 | — |
| GSK Investigational Site | Atlanta | Georgia | 30309 | — |
| GSK Investigational Site | Atlanta | Georgia | 30339 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Chicago | Illinois | 60657 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 - 5124 | — |
| GSK Investigational Site | Wichita | Kansas | 67214 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70127-0800 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | — |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87131-0001 | — |
| GSK Investigational Site | Albany | New York | 12208 | — |
| GSK Investigational Site | Buffalo | New York | 14215 | — |
| GSK Investigational Site | New York | New York | 10011 | — |
| GSK Investigational Site | New York | New York | 10014 | — |
| GSK Investigational Site | Stony Brook | New York | 11794 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Portland | Oregon | 97219 | — |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Reading | Pennsylvania | 19601 | — |
| GSK Investigational Site | Providence | Rhode Island | 02903 | — |
| GSK Investigational Site | Columbia | South Carolina | 29206-4713 | — |
| GSK Investigational Site | Dallas | Texas | 75208 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Tyler | Texas | 75708 | — |
| GSK Investigational Site | Hampton | Virginia | 23666 | — |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | — |
| GSK Investigational Site | Seattle | Washington | 98104 | — |
| GSK Investigational Site | Tacoma | Washington | 98405 | — |
| GSK Investigational Site | Green Bay | Wisconsin | 54301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00053638, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 4, 2010 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00053638 live on ClinicalTrials.gov.