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

April 28, 2011 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

730

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

April 1, 2002

Study Registration Dates

First Submitted

June 15, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 244F
  • AI455-099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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