A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients

June 23, 2005 updated by: Gilead Sciences

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml

The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

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 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.

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.
390

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.
  • Not Applicable

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St Paul's Hosp
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Centre hospitalier de l'Université de Montréal (CHUM)
  • France
      • Lyon Cedex 03, France
        • Hôpital Edouard Herriot
      • Marseille, France
        • Hôpital Sainte-Marguerite
  • Germany
      • Frankfurt, Germany
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Hamburg, Germany
        • Universitätskrankenhaus Eppendorf
      • Muenchen, Germany
        • Klinikum der Ludwig-Maximilians-Universitaet
  • United Kingdom
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • Chelsea and Westminster Hosp
      • London, United Kingdom
        • Royal Free Hosp
      • London, United Kingdom
        • Senior Lecturer in GU Medicine
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Research
      • Palm Springs, California, United States, 92262
        • ViRx Inc
      • Sacramento, California, United States, 95814
        • Ctr for AIDS Research / Education and Service (CARES)
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp / UCSF AIDS Program
      • San Francisco, California, United States, 94121
        • San Francisco VA Med Ctr
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
    • Connecticut
      • Stamford, Connecticut, United States, 06901
        • Blick Med Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Coral Gables, Florida, United States, 33146
        • Community AIDS Resource Inc
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Jacksonville, Florida, United States, 32206
        • Duval County Health Department
      • Safety Harbor, Florida, United States, 34695
        • Health Positive
      • Tampa, Florida, United States, 33609
        • Center for Quality Care
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Georgia Research Associates
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ School of Medicine
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10011
        • Bentley-Salick Med Practice
      • New York, New York, United States, 10011
        • St Luke Roosevelt Hosp
      • New York, New York, United States, 10019
        • James Jones MD
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest Univ School of Medicine
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Associates of Med and Mental Health
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Med Ctr
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ School of Medicine
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Univ of Utah Med School / Clinical Trials Ctr
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc
    • Washington
      • Seattle, Washington, United States, 98122
        • N Touch Research Corp

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
  • Have a CD4 count of 50 cells/mm3 or more.
  • Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
  • Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.

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.
Gilead Sciences

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 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).
November 2, 1999

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.
June 24, 2005

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.
June 23, 2005

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.
December 1, 1999

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.
  • 232K
  • GS-97-415

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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