NCT00002426

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Geographic Reach
5 countries

49 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Keywords

HIV-1RNA, ViralVX 478Reverse Transcriptase InhibitorsAnti-HIV AgentsViral Load

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (49)

Pacific Oaks Research

Beverly Hills, California, 90211, United States

Location

ViRx Inc

Palm Springs, California, 92262, United States

Location

Ctr for AIDS Research / Education and Service (CARES)

Sacramento, California, 95814, United States

Location

San Francisco Gen Hosp / UCSF AIDS Program

San Francisco, California, 94110, United States

Location

Kaiser Foundation Hospital

San Francisco, California, 94118, United States

Location

San Francisco VA Med Ctr

San Francisco, California, 94121, United States

Location

Blick Med Associates

Stamford, Connecticut, 06901, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Dupont Circle Physicians Group

Washington D.C., District of Columbia, 200091104, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

IDC Research Initiative

Altamonte Springs, Florida, 32701, United States

Location

Community AIDS Resource Inc

Coral Gables, Florida, 33146, United States

Location

TheraFirst Med Ctrs Inc

Fort Lauderdale, Florida, 33308, United States

Location

Duval County Health Department

Jacksonville, Florida, 32206, United States

Location

Health Positive

Safety Harbor, Florida, 34695, United States

Location

Center for Quality Care

Tampa, Florida, 33609, United States

Location

Georgia Research Associates

Atlanta, Georgia, 30342, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Indiana Univ Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Univ School of Medicine

Baltimore, Maryland, 21205, United States

Location

Albany Med College

Albany, New York, 12208, United States

Location

Bentley-Salick Med Practice

New York, New York, 10011, United States

Location

St Luke Roosevelt Hosp

New York, New York, 10011, United States

Location

James Jones MD

New York, New York, 10019, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Associates of Med and Mental Health

Tulsa, Oklahoma, 74114, United States

Location

The Research and Education Group

Portland, Oregon, 97210, United States

Location

Miriam Hosp

Providence, Rhode Island, 02906, United States

Location

Roger Williams Med Ctr

Providence, Rhode Island, 02908, United States

Location

Vanderbilt Univ School of Medicine

Nashville, Tennessee, 37212, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Univ of Texas Med Branch

Galveston, Texas, 77555, United States

Location

Thomas Street Clinic

Houston, Texas, 77009, United States

Location

Univ of Utah Med School / Clinical Trials Ctr

Salt Lake City, Utah, 84108, United States

Location

Infectious Disease Physicians Inc

Annandale, Virginia, 22203, United States

Location

N Touch Research Corp

Seattle, Washington, 98122, United States

Location

St Paul's Hosp

Vancouver, British Columbia, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Location

Centre hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

Hopital Edouard Herriot

Lyon, France

Location

Hopital Sainte-Marguerite

Marseille, France

Location

Klinikum Der Johann Wolfgang Goethe Universitat

Frankfurt, Germany

Location

Universitatskrankenhaus Eppendorf

Hamburg, Germany

Location

Klinikum der Ludwig-Maximilians-Universitaet

München, Germany

Location

Chelsea and Westminster Hosp

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Royal Free Hosp

London, United Kingdom

Location

Senior Lecturer in GU Medicine

London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

adefovir dipivoxil

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-12

Locations