Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
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
2 other identifiers
interventional
730
16 countries
76
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Jun 2000
Shorter than P25 for phase_3 hiv-infections
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 15, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedMay 4, 2011
April 1, 2011
1.8 years
June 15, 2000
April 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- 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.
You may not qualify if:
- Patients will not be eligible for this study if they:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Med Alternatives
Fort Lauderdale, Florida, 33308, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124, United States
Univ of Louisville
Louisville, Kentucky, 40292, United States
CRI of New England
Brookline, Massachusetts, 02445, United States
CRI - Springfield
Springfield, Massachusetts, 01107, United States
No Nevada HOPES
Reno, Nevada, 89520, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Univ Hospital
Oklahoma City, Oklahoma, 73104, United States
Aesculapisu Medical Health Group
Dallas, Texas, 75204, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390, United States
Univ of Texas Med Branch
Galveston, Texas, 775550835, United States
Plaza Med Ctr
Houston, Texas, 77004, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, 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, 00780, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 009091711, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 15, 2000
First Posted
August 31, 2001
Study Start
June 1, 2000
Primary Completion
April 1, 2002
Study Completion
April 1, 2002
Last Updated
May 4, 2011
Record last verified: 2011-04