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| Sponsor: | Triangle Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00006208 |
Purpose
The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Efavirenz Drug: Emtricitabine Drug: Stavudine Drug: Didanosine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine Within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naive HIV-1 Infected Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 352942050 | |
| United States, California | |
| Saint Francis Mem Hosp / HIV Care | |
| San Francisco, California, United States, 94109 | |
| St Lukes Medical Group | |
| San Diego, California, United States, 92101 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Mem Med Group Inc | |
| Long Beach, California, United States, 90806 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90027 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Orange Coast Med Group | |
| Newport Beach, California, United States, 92663 | |
| Robert Smith Medical Group | |
| San Diego, California, United States, 92103 | |
| East Bay Clinical Trial Ctr | |
| Concord, California, United States, 94520 | |
| United States, Colorado | |
| Univ of Colorado Health Ctr / Denver Gen Hosp | |
| Denver, Colorado, United States, 80262 | |
| Beacon Clinic / Boulder Community Hosp | |
| Boulder, Colorado, United States, 80304 | |
| United States, Connecticut | |
| Blick Med Associates | |
| Stamford, Connecticut, United States, 06901 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Physicans Home Service | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| South Miami Hosp | |
| Miami, Florida, United States, 33143 | |
| Gary Richmond MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Health Positive | |
| Safety Harbor, Florida, United States, 34695 | |
| Infectious Diseases Associates | |
| Sarasota, Florida, United States, 34239 | |
| Wohlfeiler, Piperator & King, MD, PA | |
| Miami Beach, Florida, United States, 33139 | |
| Larry Bush | |
| Palm Springs, Florida, United States, 33461 | |
| Infectious Disease Research Inst | |
| Tampa, Florida, United States, 33614 | |
| Hillsborough County Health Department | |
| Tampa, Florida, United States, 33602 | |
| United States, Georgia | |
| Ingenix Kern McNeill Decatur | |
| Atlanta, Georgia, United States, 30309 | |
| Infectious Disease Specialists of Atlanta | |
| Decatur, Georgia, United States, 30033 | |
| Harbin Clinic | |
| Rome, Georgia, United States, 30165 | |
| United States, Illinois | |
| Northstar Med Clinic | |
| Chicago, Illinois, United States, 60657 | |
| United States, Louisiana | |
| Tulane Univ Med Ctr / Infectious Diseases Sect | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| Fenway Community Health Ctr | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Abbott-Northwestern Hosp / Clinic 42 | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New Jersey | |
| South Jersey Infectious Diseases Inc | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, New York | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Erie County Med Ctr | |
| Buffalo, New York, United States, 14215 | |
| Liberty Medical / Cabrini Hospital / Dept of Infec Diseases | |
| New York, New York, United States, 10003 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Howard Grossman | |
| New York, New York, United States, 10011 | |
| North Shore Univ Hosp / Div of Infectious Diseases | |
| Manhasset, New York, United States, 11030 | |
| Dr Lawrence Fontana | |
| New York, New York, United States, 10003 | |
| United States, Oregon | |
| Fanno Creek Clinic | |
| Portland, Oregon, United States, 97219 | |
| United States, Rhode Island | |
| Paragon Clinical Research | |
| Cranston, Rhode Island, United States, 02920 | |
| United States, South Carolina | |
| Coastal Carolina Research Ctr | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Texas | |
| Nelson Tebedo Health Resource Ctr | |
| Dallas, Texas, United States, 75219 | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77006 | |
| Walter Gaman | |
| Irving, Texas, United States, 75038 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Diversified Med Practices, PA | |
| Houston, Texas, United States, 77027 | |
| Amelia Ct Clinic | |
| Dallas, Texas, United States, 75235 | |
| Central Texas Clinical Research | |
| Austin, Texas, United States, 78705 | |
| United States, Washington | |
| Swedish Med Ctr / Dr Peter Shalit | |
| Seattle, Washington, United States, 98104 | |
| Argentina | |
| Hospital Muniz | |
| Buenos Aires, Argentina | |
| Fundacion HUES | |
| Buenos Aires, Argentina | |
| Hospital de Agudos JM Ramos Mejia | |
| Buenos Aires, Argentina | |
| FUNCEI | |
| Buenos Aires, Argentina | |
| Hospital Interzonal Gen de Agudos Oscar Alende | |
| Mar del Plata, Argentina | |
| Canada, British Columbia | |
| Viridae Clinical Sciences / University of British Columbia | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| McMaster Univ Med Centre | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Centre De Recherche En Infectiologie | |
| Ste Foy, Quebec, Canada | |
| Montreal Gen Hosp | |
| Montreal, Quebec, Canada | |
| Chile | |
| Fundacion Arriaran | |
| Santiago, Chile | |
| Mexico | |
| Instituto Nacional de la Nutricion | |
| Mexico City, Mexico | |
| Puerto Rico | |
| San Juan Veterans Administration Med Ctr | |
| San Juan, Puerto Rico, 009275800 | |
More Information
| Study ID Numbers: | 298C, FTC-301 |
| Study First Received: | September 11, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006208 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Didanosine Drug Therapy, Combination Reverse Transcriptase Inhibitors |
Anti-HIV Agents Deoxycytidine efavirenz |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |