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Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
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, Drug Therapy, Combination, Drug Administration Schedule, RNA, Viral, Anti-HIV Agents, Viral Load

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry. Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml. Have good kidney function. Are 18 to 65 years old. Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after. Exclusion Criteria Patients will not be eligible for this study if they: Have a new AIDS-related illness diagnosed within 30 days of study entry. Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers). Have received a vaccine within 30 days of study entry. Are unable to take medications by mouth. Have ever taken tenofovir or adefovir dipivoxil. Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs. Abuse alcohol or drugs. Are pregnant or breast-feeding.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Phoenix Body Positive
  • Ocean View Internal Medicine
  • St Mary's Med Ctr
  • AIDS Healthcare Foundation-Research Center
  • Kaiser Permanente LAMC
  • LAC / USC Med Ctr / Infectious Diseases
  • Cedars Sinai Med Ctr
  • Tower Infectious Diseases / Med Associates Inc
  • Robert Scott MD
  • UCSD Med Ctr - Owen Clinic
  • Pacific Horizons Med Group
  • Kaiser Foundation Hospital
  • San Francisco VA Med Ctr
  • Harbor UCLA Med Ctr / Research and Educational Institute
  • Univ of Colorado / Health Science Ctr
  • Yale New Haven Hosp / Nathan Smith Clinic
  • Yale-New Haven Hospital
  • George Washington Univ Med Ctr
  • Physicans Home Service
  • Therafirst Med Ctr
  • ARTCTC
  • Steinhart Medical Associates
  • Univ of Miami School of Medicine
  • Hillsborough County Health Dept
  • Treasure Coast Infectious Disease Consultants
  • AIDS Research Consortium of Atlanta Inc
  • Ponce de Leon Med Ctr
  • Northstar Med Clinic
  • Bendel Med Research
  • Dr Joel Gallant
  • New England Med Ctr
  • Massachusetts Gen Hosp
  • Harper Hosp
  • Regions Hosp / HIV/AIDS Program
  • Univ of NM
  • Albany Med College
  • Bronx Lebanon Hosp Ctr
  • Brookdale Univ Hosp and Med Ctr
  • Howard Grossman
  • St Vincent's Hosp
  • Columbia Univ
  • Univ of Rochester Medical Center
  • Nalle Clinic / Clinical Research Dept
  • Ian Baird
  • Remington Davis Inc
  • Oklahoma Univ Health Science Ctr
  • Pennsylvania State College of Medicine
  • Miriam Hosp / Brown Univ
  • Dallas Veterans Administration Med Ctr
  • Nicholas Bellos
  • Thomas Street Clinic
  • Univ of Texas / Thomas Street Clinic
  • Univ TX San Antonio Health Science Ctr
  • Infectious Diseases Physicians Inc
  • Hampton Roads Med Specialists
  • Infections Ltd PS
  • Infections Ltd / Physicians Med Ctr
  • Ponce Univ Hosp
  • Clinical Research Puerto Rico Inc
  • San Juan AIDS Program

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 17, 2000
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002450
Brief Title
Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
Official Title
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2000
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 giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
Detailed Description
Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry. Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. After Week 24, changes in background antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study. While on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. Additionally, changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Drug Administration Schedule, RNA, Viral, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry. Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml. Have good kidney function. Are 18 to 65 years old. Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after. Exclusion Criteria Patients will not be eligible for this study if they: Have a new AIDS-related illness diagnosed within 30 days of study entry. Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers). Have received a vaccine within 30 days of study entry. Are unable to take medications by mouth. Have ever taken tenofovir or adefovir dipivoxil. Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs. Abuse alcohol or drugs. Are pregnant or breast-feeding.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Ocean View Internal Medicine
City
Long Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Facility Name
St Mary's Med Ctr
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
AIDS Healthcare Foundation-Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente LAMC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
LAC / USC Med Ctr / Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Tower Infectious Diseases / Med Associates Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Robert Scott MD
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCSD Med Ctr - Owen Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
921038681
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
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
Harbor UCLA Med Ctr / Research and Educational Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Yale New Haven Hosp / Nathan Smith Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
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
Physicans Home Service
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Therafirst Med Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
ARTCTC
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
Steinhart Medical Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
AIDS Research Consortium of Atlanta Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Ponce de Leon Med Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Bendel Med Research
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Dr Joel Gallant
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Regions Hosp / HIV/AIDS Program
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Univ of NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Brookdale Univ Hosp and Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112123198
Country
United States
Facility Name
Howard Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Vincent's Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Columbia Univ
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Nalle Clinic / Clinical Research Dept
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Ian Baird
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Remington Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Oklahoma Univ Health Science Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pennsylvania State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Miriam Hosp / Brown Univ
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Dallas Veterans Administration Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Nicholas Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Univ of Texas / Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Infectious Diseases Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Infections Ltd PS
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98371
Country
United States
Facility Name
Infections Ltd / Physicians Med Ctr
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Ponce Univ Hosp
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
009091711
Country
Puerto Rico
Facility Name
San Juan AIDS Program
City
Santurce
ZIP/Postal Code
00908
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients

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