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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Adefovir dipivoxil
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pacific Oaks Research
  • ViRx Inc
  • Ctr for AIDS Research / Education and Service (CARES)
  • San Francisco Gen Hosp / UCSF AIDS Program
  • Kaiser Foundation Hospital
  • San Francisco VA Med Ctr
  • Blick Med Associates
  • Georgetown Univ Med Ctr
  • Dupont Circle Physicians Group
  • George Washington Univ Med Ctr
  • IDC Research Initiative
  • Community AIDS Resource Inc
  • TheraFirst Med Ctrs Inc
  • Duval County Health Department
  • Health Positive
  • Center for Quality Care
  • Georgia Research Associates
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Indiana Univ Infectious Disease Research Clinic
  • Johns Hopkins Univ School of Medicine
  • Albany Med College
  • Bentley-Salick Med Practice
  • St Luke Roosevelt Hosp
  • James Jones MD
  • Mount Sinai Med Ctr
  • Wake Forest Univ School of Medicine
  • Associates of Med and Mental Health
  • The Research and Education Group
  • Miriam Hosp
  • Roger Williams Med Ctr
  • Vanderbilt Univ School of Medicine
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Univ of Texas Med Branch
  • Thomas Street Clinic
  • Univ of Utah Med School / Clinical Trials Ctr
  • Infectious Disease Physicians Inc
  • N Touch Research Corp
  • St Paul's Hosp
  • Sunnybrook Health Science Centre
  • Centre hospitalier de l'Universite de Montreal (CHUM)
  • Hopital Edouard Herriot
  • Hopital Sainte-Marguerite
  • Klinikum Der Johann Wolfgang Goethe Universitat
  • Universitatskrankenhaus Eppendorf
  • Klinikum der Ludwig-Maximilians-Universitaet
  • Chelsea and Westminster Hosp
  • King's College Hospital
  • Royal Free Hosp
  • Senior Lecturer in GU Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002426
Brief Title
A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
390 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
ViRx Inc
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Ctr for AIDS Research / Education and Service (CARES)
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
San Francisco Gen Hosp / UCSF AIDS Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
San Francisco VA Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Blick Med Associates
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06901
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Community AIDS Resource Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Duval County Health Department
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Health Positive
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Center for Quality Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Georgia Research Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Univ School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bentley-Salick Med Practice
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Luke Roosevelt Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
James Jones MD
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Wake Forest Univ School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Associates of Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Vanderbilt Univ School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Univ of Utah Med School / Clinical Trials Ctr
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
N Touch Research Corp
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
St Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Edouard Herriot
City
Lyon Cedex 03
Country
France
Facility Name
Hopital Sainte-Marguerite
City
Marseille
Country
France
Facility Name
Klinikum Der Johann Wolfgang Goethe Universitat
City
Frankfurt
Country
Germany
Facility Name
Universitatskrankenhaus Eppendorf
City
Hamburg
Country
Germany
Facility Name
Klinikum der Ludwig-Maximilians-Universitaet
City
Muenchen
Country
Germany
Facility Name
Chelsea and Westminster Hosp
City
London
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free Hosp
City
London
Country
United Kingdom
Facility Name
Senior Lecturer in GU Medicine
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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