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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
730

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings