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

NCT ID: NCT00002426

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Adefovir dipivoxil

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Locations

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Pacific Oaks Research

Beverly Hills, California, United States

Site Status

ViRx Inc

Palm Springs, California, United States

Site Status

Ctr for AIDS Research / Education and Service (CARES)

Sacramento, California, United States

Site Status

San Francisco Gen Hosp / UCSF AIDS Program

San Francisco, California, United States

Site Status

Kaiser Foundation Hospital

San Francisco, California, United States

Site Status

San Francisco VA Med Ctr

San Francisco, California, United States

Site Status

Blick Med Associates

Stamford, Connecticut, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

Site Status

George Washington Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

IDC Research Initiative

Altamonte Springs, Florida, United States

Site Status

Community AIDS Resource Inc

Coral Gables, Florida, United States

Site Status

TheraFirst Med Ctrs Inc

Fort Lauderdale, Florida, United States

Site Status

Duval County Health Department

Jacksonville, Florida, United States

Site Status

Health Positive

Safety Harbor, Florida, United States

Site Status

Center for Quality Care

Tampa, Florida, United States

Site Status

Georgia Research Associates

Atlanta, Georgia, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Indiana Univ Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Univ School of Medicine

Baltimore, Maryland, United States

Site Status

Albany Med College

Albany, New York, United States

Site Status

Bentley-Salick Med Practice

New York, New York, United States

Site Status

St Luke Roosevelt Hosp

New York, New York, United States

Site Status

James Jones MD

New York, New York, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Associates of Med and Mental Health

Tulsa, Oklahoma, United States

Site Status

The Research and Education Group

Portland, Oregon, United States

Site Status

Miriam Hosp

Providence, Rhode Island, United States

Site Status

Roger Williams Med Ctr

Providence, Rhode Island, United States

Site Status

Vanderbilt Univ School of Medicine

Nashville, Tennessee, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Univ of Texas Med Branch

Galveston, Texas, United States

Site Status

Thomas Street Clinic

Houston, Texas, United States

Site Status

Univ of Utah Med School / Clinical Trials Ctr

Salt Lake City, Utah, United States

Site Status

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Site Status

N Touch Research Corp

Seattle, Washington, United States

Site Status

St Paul's Hosp

Vancouver, British Columbia, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status

Hopital Edouard Herriot

Lyon, , France

Site Status

Hopital Sainte-Marguerite

Marseille, , France

Site Status

Klinikum Der Johann Wolfgang Goethe Universitat

Frankfurt, , Germany

Site Status

Universitatskrankenhaus Eppendorf

Hamburg, , Germany

Site Status

Klinikum der Ludwig-Maximilians-Universitaet

München, , Germany

Site Status

Chelsea and Westminster Hosp

London, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Royal Free Hosp

London, , United Kingdom

Site Status

Senior Lecturer in GU Medicine

London, , United Kingdom

Site Status

Countries

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United States Canada France Germany United Kingdom

Other Identifiers

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GS-97-415

Identifier Type: -

Identifier Source: secondary_id

232K

Identifier Type: -

Identifier Source: org_study_id