Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00005918
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 730
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Tan tock Seng Hosp
Srev Du Pr Gentilini
🇫🇷Paris Cedex 13, France
Hopital Pontachaillou
🇫🇷Rennes, France
CAICI
🇦🇷Rosario Santa Fe, Argentina
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Univ of Louisville
🇺🇸Louisville, Kentucky, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Plaza Med Ctr
🇺🇸Houston, Texas, United States
No Nevada HOPES
🇺🇸Reno, Nevada, United States
Univ of Texas Southwestern Med Ctr
🇺🇸Dallas, Texas, United States
Universidade Estadual de Botucatu
🇧🇷Botucatu-SP, Brazil
Instituto de Infectologia Emilio Ribas
🇧🇷Sao Paulo, Brazil
Fernando Silva Nieto MD
🇦🇷Prov Bs As, Argentina
Marcelo Beltran
🇦🇷San Isidro, Argentina
University Hospital Gent
🇧🇪Gent, Belgium
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Arnaldo Casiro MD
🇦🇷Buenos Aires, Argentina
Elida Pallone MD
🇦🇷Buenos Aires, Argentina
Prahran Market Clinic
🇦🇺South Yarra, Australia
Universita Di Bari
🇮🇹Bari, Italy
Instituto Nacional de la Nutricion
🇲🇽Mexico City, Mexico
Ospedale Luigi Cacco Moroni
🇮🇹Milano, Italy
Ospedale Cotugno
🇮🇹Napoli, Italy
Dr Roger P Leblanc
🇨🇦Montreal, Quebec, Canada
Ospedale Amedeo di Savoia
🇮🇹Torino, Italy
Federal University of Minas, Dept. of Pediatrics
🇧🇷Belo Horizonte-MG, Brazil
Fundacao Zerbini Casa Da Aids
🇧🇷Sao Paulo, Brazil
Clinique Medicale L'Actuele
🇨🇦Montreal, Quebec, Canada
Kaplan Med Ctr
🇮🇱Rehovot, Israel
Hopital De L'Hotel Dieu
🇫🇷Nantes, France
Reparto Malattie Infettive
🇮🇹Antella, Italy
Ospedale Cisanello
🇮🇹Pisa, Italy
Ospedale Amedeo de Savoia
🇮🇹Torino, Italy
Clinique Medicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Hopital Saint Andre
🇫🇷Bordeaux, France
Sheba Med Ctr
🇮🇱Tel Hashomer, Israel
Tygerberg Hosp
🇿🇦Cape Town, South Africa
Innovir Institute / Saffer House
🇿🇦Johannesburg, South Africa
Alberto Orneals MD
🇲🇽Tijuana, Mexico
Hosp De Santa Maria
🇵🇹Lisboa, Portugal
Johannesburg Hosp
🇿🇦Johannesburg, South Africa
Hosp Clinic
🇪🇸Barcelona, Spain
Hospital Distrital de Almada
🇵🇹Almada, Portugal
San Cristobal Hosp
🇵🇷Coto Laurel, Ponce, Puerto Rico
Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
🇹🇭Bangkok, Thailand
Federal AIDS Ctr
🇷🇺Moscow, Russian Federation
Nina Volkova MD
🇷🇺St Petersburg, Russian Federation
Embassy Drive Medical Centre
🇿🇦Pretoria, South Africa
Hosp son Dureta
🇪🇸Palma de Mallorca, Spain
CRI - Springfield
🇺🇸Springfield, Massachusetts, United States
Luis Maria Zieher MD
🇦🇷Buenos Aires, Argentina
Hopital Edouard Herriot
🇫🇷Lyon Cedex 03, France
Domaine Universitaire Du SART-TILMAN
🇧🇪Liege, Belgium
Ospedali Riuniti
🇮🇹Bergamo, Italy
Hospital General
🇲🇽Mexico City, Mexico
Chris Hani Baragwanath Hosp
🇿🇦Johannesburg, South Africa
Univ Hospital
🇺🇸Oklahoma City, Oklahoma, United States
CRI of New England
🇺🇸Brookline, Massachusetts, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Hosp Gregorio Maranon
🇪🇸Madrid, Spain
Med Alternatives
🇺🇸Fort Lauderdale, Florida, United States
Aesculapisu Medical Health Group
🇺🇸Dallas, Texas, United States
Claudia Rodriguez MD
🇦🇷Buenos Aires, Argentina
Fundacion Huesped
🇦🇷Buenos Aires, Argentina
Hosp de Navarra
🇪🇸Pamplona, Spain
Hugo Ree MD
🇦🇺Brisbane, Australia
Ricardo Leite Hayden
🇧🇷Santos, Brazil
Instituto Nacional de Enfermedades Respiratorias
🇲🇽Mexico City, Mexico
Hospital Universidade De Coimbra
🇵🇹Coimbra, Portugal
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
Bamrasnaradura Hosp
🇹🇭Nontaburi, Thailand
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States