Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
NCT ID: NCT00005918
Last Updated: 2011-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
730 participants
INTERVENTIONAL
2000-06-30
2002-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Efavirenz
Lamivudine
Stavudine
Eligibility Criteria
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Inclusion Criteria
* Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18).
* Have a viral load of at least 2,000 copies/ml within 21 days of study entry.
* Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry.
* Agree to use a barrier method of birth control (such as condoms) during the study.
* Are available for follow-up for at least 56 weeks.
Exclusion Criteria
* Are pregnant or breast-feeding.
* Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 30 days and within 14 days of study entry.
* Have a new opportunistic (HIV-related) infection or condition requiring treatment.
* Have acute (early) HIV infection.
* Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry.
* Abuse alcohol or drugs.
* Have active hepatitis within 30 days prior to study entry.
* Have a history of peripheral neuropathy (a condition affecting the nervous system).
* Cannot take medications by mouth.
* Are allergic to certain antiviral drugs.
* Need to take certain medications that should not be taken with EFV.
* Have certain other conditions or prior treatments that might affect the study.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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AIDS Healthcare Foundation
Los Angeles, California, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Med Alternatives
Fort Lauderdale, Florida, United States
Hillsborough County Health Dept
Tampa, Florida, United States
The CORE Ctr
Chicago, Illinois, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Univ of Louisville
Louisville, Kentucky, United States
CRI of New England
Brookline, Massachusetts, United States
CRI - Springfield
Springfield, Massachusetts, United States
No Nevada HOPES
Reno, Nevada, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Univ Hospital
Oklahoma City, Oklahoma, United States
Aesculapisu Medical Health Group
Dallas, Texas, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States
Univ of Texas Med Branch
Galveston, Texas, United States
Plaza Med Ctr
Houston, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Arnaldo Casiro MD
Buenos Aires, , Argentina
Claudia Rodriguez MD
Buenos Aires, , Argentina
Elida Pallone MD
Buenos Aires, , Argentina
Fundacion Huesped
Buenos Aires, , Argentina
Luis Maria Zieher MD
Buenos Aires, , Argentina
Fernando Silva Nieto MD
Prov Bs As, , Argentina
CAICI
Rosario Santa Fe, , Argentina
Marcelo Beltran
San Isidro, , Argentina
Hugo Ree MD
Brisbane, , Australia
Prahran Market Clinic
South Yarra, , Australia
University Hospital Gent
Ghent, , Belgium
Domaine Universitaire Du SART-TILMAN
Liège, , Belgium
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte-MG, , Brazil
Universidade Estadual de Botucatu
Botucatu-SP, , Brazil
Ricardo Leite Hayden
Santos, , Brazil
Fundacao Zerbini Casa Da Aids
São Paulo, , Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, , Brazil
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Dr Roger P Leblanc
Montreal, Quebec, Canada
Hopital Saint Andre
Bordeaux, , France
Hopital Edouard Herriot
Lyon, , France
Hopital De L'Hotel Dieu
Nantes, , France
Srev Du Pr Gentilini
Paris, , France
Hopital Pontachaillou
Rennes, , France
Kaplan Med Ctr
Rehovot, , Israel
Sheba Med Ctr
Tel Litwinsky, , Israel
Reparto Malattie Infettive
Antella, , Italy
Universita Di Bari
Bari, , Italy
Ospedali Riuniti
Bergamo, , Italy
Ospedale Luigi Cacco Moroni
Milan, , Italy
Ospedale Cotugno
Napoli, , Italy
Ospedale Cisanello
Pisa, , Italy
Ospedale Amedeo de Savoia
Torino, , Italy
Ospedale Amedeo di Savoia
Torino, , Italy
Hospital General
Mexico City, , Mexico
Instituto Nacional de Enfermedades Respiratorias
Mexico City, , Mexico
Instituto Nacional de la Nutricion
Mexico City, , Mexico
Alberto Orneals MD
Tijuana, , Mexico
Hospital Distrital de Almada
Almada, , Portugal
Hospital Universidade De Coimbra
Coimbra, , Portugal
Hosp De Santa Maria
Lisbon, , Portugal
San Cristobal Hosp
Coto Laurel, Ponce, , Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, , Puerto Rico
Federal AIDS Ctr
Moscow, , Russia
Nina Volkova MD
Saint Petersburg, , Russia
Tygerberg Hosp
Cape Town, , South Africa
Chris Hani Baragwanath Hosp
Johannesburg, , South Africa
Innovir Institute / Saffer House
Johannesburg, , South Africa
Johannesburg Hosp
Johannesburg, , South Africa
Embassy Drive Medical Centre
Pretoria, , South Africa
Hosp Clinic
Barcelona, , Spain
Hosp Gregorio Maranon
Madrid, , Spain
Hosp son Dureta
Palma de Mallorca, , Spain
Hosp de Navarra
Pamplona, , Spain
Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
Bangkok, , Thailand
Bamrasnaradura Hosp
Nontaburi, , Thailand
Tan tock Seng Hosp
, ,
Countries
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Other Identifiers
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AI455-099
Identifier Type: -
Identifier Source: secondary_id
244F
Identifier Type: -
Identifier Source: org_study_id
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