A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00053638
First received: February 4, 2003
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: efavirenz Drug: tenofovir Drug: abacavir/lamivudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Lamivudine
Abacavir
Tenofovir
Efavirenz
Abacavir sulfate
Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Viral load response at 48 weeks [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
- Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics [ Time Frame: 48 weeks ]
| Estimated Enrollment: | 345 |
| Study Start Date: | February 2003 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: efavirenz
Drug: tenofovir
Drug: abacavir/lamivudine
- efavirenz
- tenofovir
- abacavir/lamivudine
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- Enrolled in other HIV treatment studies.
- Pregnant or breastfeeding.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053638
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| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94115-1931 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80205 | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80220 | |
| GSK Investigational Site | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20007-2113 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20009 | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Florida | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33145 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33316 | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| GSK Investigational Site | |
| Fort Myers, Florida, United States, 33901 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32206 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33133 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| North Miami, Florida, United States, 33161 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32804 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33602 | |
| GSK Investigational Site | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30339 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| GSK Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60657 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 - 5124 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| New Orleans, Louisiana, United States, 70127-0800 | |
| GSK Investigational Site | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Hillsborough, New Jersey, United States, 08844 | |
| United States, New Mexico | |
| GSK Investigational Site | |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| United States, New York | |
| GSK Investigational Site | |
| Albany, New York, United States, 12208 | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14215 | |
| GSK Investigational Site | |
| New York, New York, United States, 10014 | |
| GSK Investigational Site | |
| New York, New York, United States, 10011 | |
| GSK Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97219 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| GSK Investigational Site | |
| Reading, Pennsylvania, United States, 19601 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29206-4713 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75208 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Tyler, Texas, United States, 75708 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Hampton, Virginia, United States, 23666 | |
| GSK Investigational Site | |
| Lynchburg, Virginia, United States, 24501 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98104 | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Green Bay, Wisconsin, United States, 54301 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00053638 History of Changes |
| Other Study ID Numbers: | ESS30009 |
| Study First Received: | February 4, 2003 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
HIV-1 Efavirenz Tenofovir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine Tenofovir |
Tenofovir disoproxil Efavirenz Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 18, 2013