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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
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 Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma. CD4 count >= 200 cells/mm3. No new AIDS-defining event within the past 2 months. Life expectancy at least 1 year. Consent of parent or guardian if less than 18 years old. Tolerated antiretroviral therapy for the past 2 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy. Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication. Malignancy other than Kaposi's sarcoma or basal cell carcinoma. Concurrent Medication: Excluded: Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons. Isoniazid. Rifampin. Investigational agents (unless approved by sponsor). Systemic chemotherapeutic agents. Prior Medication: Excluded: Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks. Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month. Systemic therapy for KS within the past month. Required: Antiretroviral regimen other than study drug. Required: Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.

Sites / Locations

  • Univ of Alabama at Birmingham
  • East Bay AIDS Ctr
  • Kraus Med Partners
  • San Francisco Gen Hosp
  • Santa Clara Valley Med Ctr
  • San Mateo County Med Ctr / San Mateo County AIDS Prog
  • Pacific Oaks Research
  • Harbor UCLA Med Ctr
  • Georgetown Univ Med Ctr
  • Institute for Clinical Research
  • Univ of South Florida
  • AIDS Research Consortium of Atlanta
  • Chicago Ctr for Clinical Research
  • Northwestern Univ Med Ctr
  • Tulane Univ / Tulane / LSU Clinical Trials Unit
  • Harvard Univ / Massachusetts Gen Hosp
  • Wayne State Univ / Univ Health Ctr
  • Albany Med College / Clinical Pharmacy Studies
  • Saint Vincent's Med Ctr
  • Carolinas Med Ctr
  • The Research and Education Group
  • Vanderbilt Univ Med Ctr
  • Dallas VA Med Ctr
  • Univ of Texas
  • Houston Clinical Research Network
  • Univ of Utah School of Medicine
  • Univ of Wisconsin

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
NCT00002161
Brief Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
Study Type
Interventional

2. Study Status

Record Verification Date
May 1997
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
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
Detailed Description
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma. CD4 count >= 200 cells/mm3. No new AIDS-defining event within the past 2 months. Life expectancy at least 1 year. Consent of parent or guardian if less than 18 years old. Tolerated antiretroviral therapy for the past 2 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy. Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication. Malignancy other than Kaposi's sarcoma or basal cell carcinoma. Concurrent Medication: Excluded: Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons. Isoniazid. Rifampin. Investigational agents (unless approved by sponsor). Systemic chemotherapeutic agents. Prior Medication: Excluded: Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks. Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month. Systemic therapy for KS within the past month. Required: Antiretroviral regimen other than study drug. Required: Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Kraus Med Partners
City
Los Angeles
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
San Mateo County Med Ctr / San Mateo County AIDS Prog
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
Pacific Oaks Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
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
Institute for Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Univ of South Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
303081962
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Northwestern Univ Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tulane Univ / Tulane / LSU Clinical Trials Unit
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Harvard Univ / Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Wayne State Univ / Univ Health Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Albany Med College / Clinical Pharmacy Studies
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Saint Vincent's Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Dallas VA Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Univ of Texas
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Univ of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3

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