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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00005918
First received: June 15, 2000
Last updated: April 28, 2011
Last verified: April 2011
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 730
Study Start Date: June 2000
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005918

  Hide Study Locations
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
Med Alternatives
Fort Lauderdale, Florida, United States, 33308
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
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
Aesculapisu Medical Health Group
Dallas, Texas, United States, 75204
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States, 75390
Univ of Texas Med Branch
Galveston, Texas, United States, 775550835
Plaza Med Ctr
Houston, Texas, United States, 77004
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Argentina
Arnaldo Casiro MD
Buenos Aires, Argentina
Claudia Rodriguez 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
CAICI
Rosario Santa Fe, Argentina
Marcelo Beltran
San Isidro, Argentina
Australia
Hugo Ree MD
Brisbane, Australia
Prahran Market Clinic
South Yarra, Australia
Belgium
University Hospital Gent
Gent, Belgium
Domaine Universitaire Du SART-TILMAN
Liege, Belgium
Brazil
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
Sao Paulo, 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
Kaplan Med Ctr
Rehovot, Israel
Sheba Med Ctr
Tel Hashomer, Israel
Italy
Reparto Malattie Infettive
Antella, Italy
Universita Di Bari
Bari, Italy
Ospedali Riuniti
Bergamo, Italy
Ospedale Luigi Cacco Moroni
Milano, Italy
Ospedale Cotugno
Napoli, Italy
Ospedale Cisanello
Pisa, Italy
Ospedale Amedeo de Savoia
Torino, Italy
Ospedale Amedeo di Savoia
Torino, 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
Hospital Distrital de Almada
Almada, Portugal
Hospital Universidade De Coimbra
Coimbra, Portugal
Hosp De Santa Maria
Lisboa, Portugal
Puerto Rico
San Cristobal Hosp
Coto Laurel, Ponce, Puerto Rico, 00780
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 009091711
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
Chris Hani Baragwanath Hosp
Johannesburg, South Africa
Embassy Drive Medical Centre
Pretoria, South Africa
Spain
Hosp Clinic
Barcelona, Spain
Hosp Gregorio Maranon
Madrid, Spain
Hosp son Dureta
Palma de Mallorca, Spain
Hosp de Navarra
Pamplona, Spain
Thailand
Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
Bangkok, Thailand
Bamrasnaradura Hosp
Nontaburi, Thailand
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005918     History of Changes
Other Study ID Numbers: 244F, AI455-099
Study First Received: June 15, 2000
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Drug Therapy, Combination
Stavudine
Lamivudine
RNA, Viral
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
efavirenz

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Efavirenz
Lamivudine
Stavudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites

ClinicalTrials.gov processed this record on September 22, 2014