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Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Efavirenz
Lamivudine
Stavudine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

  • AIDS Healthcare Foundation
  • Whitman Walker Clinic
  • IDC Research Initiative
  • Med Alternatives
  • Hillsborough County Health Dept
  • The CORE Ctr
  • Univ of Kansas School of Medicine
  • Univ of Louisville
  • CRI of New England
  • CRI - Springfield
  • No Nevada HOPES
  • Saint Luke's - Roosevelt Hosp Ctr
  • Univ Hospital
  • Aesculapisu Medical Health Group
  • Univ of Texas Southwestern Med Ctr
  • Univ of Texas Med Branch
  • Plaza Med Ctr
  • Hampton Roads Med Specialists
  • Arnaldo Casiro MD
  • Claudia Rodriguez MD
  • Elida Pallone MD
  • Fundacion Huesped
  • Luis Maria Zieher MD
  • Fernando Silva Nieto MD
  • CAICI
  • Marcelo Beltran
  • Hugo Ree MD
  • Prahran Market Clinic
  • University Hospital Gent
  • Domaine Universitaire Du SART-TILMAN
  • Federal University of Minas, Dept. of Pediatrics
  • Universidade Estadual de Botucatu
  • Ricardo Leite Hayden
  • Fundacao Zerbini Casa Da Aids
  • Instituto de Infectologia Emilio Ribas
  • Saint Paul's Hosp
  • Clinique Medicale du Quartier Latin
  • Clinique Medicale L'Actuele
  • Dr Roger P Leblanc
  • Hopital Saint Andre
  • Hopital Edouard Herriot
  • Hopital De L'Hotel Dieu
  • Srev Du Pr Gentilini
  • Hopital Pontachaillou
  • Kaplan Med Ctr
  • Sheba Med Ctr
  • Reparto Malattie Infettive
  • Universita Di Bari
  • Ospedali Riuniti
  • Ospedale Luigi Cacco Moroni
  • Ospedale Cotugno
  • Ospedale Cisanello
  • Ospedale Amedeo de Savoia
  • Ospedale Amedeo di Savoia
  • Hospital General
  • Instituto Nacional de Enfermedades Respiratorias
  • Instituto Nacional de la Nutricion
  • Alberto Orneals MD
  • Hospital Distrital de Almada
  • Hospital Universidade De Coimbra
  • Hosp De Santa Maria
  • San Cristobal Hosp
  • Clinical Research Puerto Rico Inc
  • Federal AIDS Ctr
  • Nina Volkova MD
  • Tygerberg Hosp
  • Chris Hani Baragwanath Hosp
  • Innovir Institute / Saffer House
  • Johannesburg Hosp
  • Embassy Drive Medical Centre
  • Hosp Clinic
  • Hosp Gregorio Maranon
  • Hosp son Dureta
  • Hosp de Navarra
  • Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
  • Bamrasnaradura Hosp
  • Tan tock Seng Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 15, 2000
Last Updated
April 28, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00005918
Brief Title
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
730 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Med Alternatives
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
672143124
Country
United States
Facility Name
Univ of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
CRI - Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
No Nevada HOPES
City
Reno
State/Province
Nevada
ZIP/Postal Code
89520
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Univ Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Aesculapisu Medical Health Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Plaza Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Arnaldo Casiro MD
City
Buenos Aires
Country
Argentina
Facility Name
Claudia Rodriguez MD
City
Buenos Aires
Country
Argentina
Facility Name
Elida Pallone MD
City
Buenos Aires
Country
Argentina
Facility Name
Fundacion Huesped
City
Buenos Aires
Country
Argentina
Facility Name
Luis Maria Zieher MD
City
Buenos Aires
Country
Argentina
Facility Name
Fernando Silva Nieto MD
City
Prov Bs As
Country
Argentina
Facility Name
CAICI
City
Rosario Santa Fe
Country
Argentina
Facility Name
Marcelo Beltran
City
San Isidro
Country
Argentina
Facility Name
Hugo Ree MD
City
Brisbane
Country
Australia
Facility Name
Prahran Market Clinic
City
South Yarra
Country
Australia
Facility Name
University Hospital Gent
City
Gent
Country
Belgium
Facility Name
Domaine Universitaire Du SART-TILMAN
City
Liege
Country
Belgium
Facility Name
Federal University of Minas, Dept. of Pediatrics
City
Belo Horizonte-MG
Country
Brazil
Facility Name
Universidade Estadual de Botucatu
City
Botucatu-SP
Country
Brazil
Facility Name
Ricardo Leite Hayden
City
Santos
Country
Brazil
Facility Name
Fundacao Zerbini Casa Da Aids
City
Sao Paulo
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas
City
Sao Paulo
Country
Brazil
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Dr Roger P Leblanc
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Saint Andre
City
Bordeaux
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon Cedex 03
Country
France
Facility Name
Hopital De L'Hotel Dieu
City
Nantes
Country
France
Facility Name
Srev Du Pr Gentilini
City
Paris Cedex 13
Country
France
Facility Name
Hopital Pontachaillou
City
Rennes
Country
France
Facility Name
Kaplan Med Ctr
City
Rehovot
Country
Israel
Facility Name
Sheba Med Ctr
City
Tel Hashomer
Country
Israel
Facility Name
Reparto Malattie Infettive
City
Antella
Country
Italy
Facility Name
Universita Di Bari
City
Bari
Country
Italy
Facility Name
Ospedali Riuniti
City
Bergamo
Country
Italy
Facility Name
Ospedale Luigi Cacco Moroni
City
Milano
Country
Italy
Facility Name
Ospedale Cotugno
City
Napoli
Country
Italy
Facility Name
Ospedale Cisanello
City
Pisa
Country
Italy
Facility Name
Ospedale Amedeo de Savoia
City
Torino
Country
Italy
Facility Name
Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
Hospital General
City
Mexico City
Country
Mexico
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
Country
Mexico
Facility Name
Instituto Nacional de la Nutricion
City
Mexico City
Country
Mexico
Facility Name
Alberto Orneals MD
City
Tijuana
Country
Mexico
Facility Name
Hospital Distrital de Almada
City
Almada
Country
Portugal
Facility Name
Hospital Universidade De Coimbra
City
Coimbra
Country
Portugal
Facility Name
Hosp De Santa Maria
City
Lisboa
Country
Portugal
Facility Name
San Cristobal Hosp
City
Coto Laurel, Ponce
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
009091711
Country
Puerto Rico
Facility Name
Federal AIDS Ctr
City
Moscow
Country
Russian Federation
Facility Name
Nina Volkova MD
City
St Petersburg
Country
Russian Federation
Facility Name
Tygerberg Hosp
City
Cape Town
Country
South Africa
Facility Name
Chris Hani Baragwanath Hosp
City
Johannesburg
Country
South Africa
Facility Name
Innovir Institute / Saffer House
City
Johannesburg
Country
South Africa
Facility Name
Johannesburg Hosp
City
Johannesburg
Country
South Africa
Facility Name
Embassy Drive Medical Centre
City
Pretoria
Country
South Africa
Facility Name
Hosp Clinic
City
Barcelona
Country
Spain
Facility Name
Hosp Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Hosp son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hosp de Navarra
City
Pamplona
Country
Spain
Facility Name
Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
City
Bangkok
Country
Thailand
Facility Name
Bamrasnaradura Hosp
City
Nontaburi
Country
Thailand
Facility Name
Tan tock Seng Hosp

12. IPD Sharing Statement

Learn more about this trial

Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

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