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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00005918 |
Purpose
The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Efavirenz Drug: Lamivudine Drug: Stavudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy |
| Estimated Enrollment: | 730 |
| Study Start Date: | June 2000 |
Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).
Eligibility| Ages Eligible for Study: | 12 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, California | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90027 | |
| United States, District of Columbia | |
| Whitman Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Hillsborough County Health Dept | |
| Tampa, Florida, United States, 33602 | |
| Med Alternatives | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Illinois | |
| The CORE Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 672143124 | |
| United States, Kentucky | |
| Univ of Louisville | |
| Louisville, Kentucky, United States, 40292 | |
| United States, Massachusetts | |
| CRI of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| CRI - Springfield | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Nevada | |
| No Nevada HOPES | |
| Reno, Nevada, United States, 89520 | |
| United States, New York | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| United States, Oklahoma | |
| Univ Hospital | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Texas | |
| Plaza Med Ctr | |
| Houston, Texas, United States, 77004 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 775550835 | |
| Univ of Texas Southwestern Med Ctr | |
| Dallas, Texas, United States, 75390 | |
| Aesculapisu Medical Health Group | |
| Dallas, Texas, United States, 75204 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| Argentina | |
| CAICI | |
| Rosario Santa Fe, Argentina | |
| Arnaldo Casiro MD | |
| Buenos Aires, Argentina | |
| Fundacion Huesped | |
| Buenos Aires, Argentina | |
| Elida Pallone MD | |
| Buenos Aires, Argentina | |
| Luis Maria Zieher MD | |
| Buenos Aires, Argentina | |
| Fernando Silva Nieto MD | |
| Prov Bs As, Argentina | |
| Claudia Rodriguez MD | |
| Buenos Aires, Argentina | |
| Marcelo Beltran | |
| San Isidro, Argentina | |
| Australia | |
| Prahran Market Clinic | |
| South Yarra, Australia | |
| Hugo Ree MD | |
| Brisbane, Australia | |
| Belgium | |
| University Hospital Gent | |
| Gent, Belgium | |
| Domaine Universitaire Du SART-TILMAN | |
| Liege, Belgium | |
| Brazil | |
| Fundacao Zerbini Casa Da Aids | |
| Sao Paulo, Brazil | |
| Ricardo Leite Hayden | |
| Santos, Brazil | |
| Federal University of Minas, Dept. of Pediatrics | |
| Belo Horizonte-MG, Brazil | |
| Universidade Estadual de Botucatu | |
| Botucatu-SP, Brazil | |
| Instituto de Infectologia Emilio Ribas | |
| Sao Paulo, Brazil | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Quebec | |
| Clinique Medicale L'Actuele | |
| Montreal, Quebec, Canada | |
| Dr Roger P Leblanc | |
| Montreal, Quebec, Canada | |
| Clinique Medicale du Quartier Latin | |
| Montreal, Quebec, Canada | |
| France | |
| Hopital Saint Andre | |
| Bordeaux, France | |
| Hopital Edouard Herriot | |
| Lyon Cedex 03, France | |
| Hopital De L'Hotel Dieu | |
| Nantes, France | |
| Srev Du Pr Gentilini | |
| Paris Cedex 13, France | |
| Hopital Pontachaillou | |
| Rennes, France | |
| Israel | |
| Sheba Med Ctr | |
| Tel Hashomer, Israel | |
| Kaplan Med Ctr | |
| Rehovot, Israel | |
| Italy | |
| Ospedale Luigi Cacco Moroni | |
| Milano, Italy | |
| Reparto Malattie Infettive | |
| Antella, Italy | |
| Ospedale Cotugno | |
| Napoli, Italy | |
| Ospedali Riuniti | |
| Bergamo, Italy | |
| Ospedale Amedeo de Savoia | |
| Torino, Italy | |
| Ospedale Cisanello | |
| Pisa, Italy | |
| Ospedale Amedeo di Savoia | |
| Torino, Italy | |
| Universita Di Bari | |
| Bari, Italy | |
| Mexico | |
| Instituto Nacional de la Nutricion | |
| Mexico City, Mexico | |
| Instituto Nacional de Enfermedades Respiratorias | |
| Mexico City, Mexico | |
| Hospital General | |
| Mexico City, Mexico | |
| Alberto Orneals MD | |
| Tijuana, Mexico | |
| Portugal | |
| Hosp De Santa Maria | |
| Lisboa, Portugal | |
| Hospital Universidade De Coimbra | |
| Coimbra, Portugal | |
| Hospital Distrital de Almada | |
| Almada, Portugal | |
| Puerto Rico | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 009091711 | |
| San Cristobal Hosp | |
| Coto Laurel, Ponce, Puerto Rico, 00780 | |
| Russian Federation | |
| Federal AIDS Ctr | |
| Moscow, Russian Federation | |
| Nina Volkova MD | |
| St Petersburg, Russian Federation | |
| Singapore | |
| Tan tock Seng Hosp | |
| Unknown, Singapore | |
| South Africa | |
| Tygerberg Hosp | |
| Cape Town, South Africa | |
| Johannesburg Hosp | |
| Johannesburg, South Africa | |
| Innovir Institute / Saffer House | |
| Johannesburg, South Africa | |
| Embassy Drive Medical Centre | |
| Pretoria, South Africa | |
| Chris Hani Baragwanath Hosp | |
| Johannesburg, South Africa | |
| Spain | |
| Hosp Clinic | |
| Barcelona, Spain | |
| Hosp de Navarra | |
| Pamplona, Spain | |
| Hosp son Dureta | |
| Palma de Mallorca, Spain | |
| Hosp Gregorio Maranon | |
| Madrid, Spain | |
| Thailand | |
| Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab | |
| Bangkok, Thailand | |
| Bamrasnaradura Hosp | |
| Nontaburi, Thailand | |
More Information
| Study ID Numbers: | 244F, AI455-099 |
| Study First Received: | June 15, 2000 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00005918 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Stavudine Lamivudine RNA, Viral Dosage Forms |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors 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 HIV Infections Sexually Transmitted Diseases Lentivirus Infections |