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

Sponsor:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002450

Purpose

The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.

Condition	Intervention	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

600

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002450

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Locations

United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
United States, California
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
UCSD Med Ctr - Owen Clinic
San Diego, California, United States, 921038681
Pacific Horizons Med Group
San Francisco, California, United States, 94115
Robert Scott MD
Oakland, California, United States, 94609
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States, 90048
St Mary's Med Ctr
Long Beach, California, United States, 90813
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States, 90033
AIDS Healthcare Foundation-Research Center
Los Angeles, California, United States, 90027
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, United States, 90502
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
San Francisco VA Med Ctr
San Francisco, California, United States, 94121
Ocean View Internal Medicine
Long Beach, California, United States, 90803
Kaiser Foundation Hospital
San Francisco, California, United States, 94118
United States, Colorado
Univ of Colorado / Health Science Ctr
Denver, Colorado, United States, 80262
United States, Connecticut
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, United States, 06504
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06504
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Physicans Home Service
Washington, District of Columbia, United States, 20037
United States, Florida
Steinhart Medical Associates
Miami, Florida, United States, 33133
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Therafirst Med Ctr
Fort Lauderdale, Florida, United States, 33308
Hillsborough County Health Dept
Tampa, Florida, United States, 33602
ARTCTC
Fort Pierce, Florida, United States, 34950
United States, Georgia
Ponce de Leon Med Ctr
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, United States, 30308
United States, Illinois
Northstar Med Clinic
Chicago, Illinois, United States, 60657
United States, Louisiana
Bendel Med Research
Lafayette, Louisiana, United States, 70503
United States, Maryland
Dr Joel Gallant
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, Michigan
Harper Hosp
Detroit, Michigan, United States, 48201
United States, Minnesota
Regions Hosp / HIV/AIDS Program
St. Paul, Minnesota, United States, 55101
United States, New Mexico
Univ of NM
Albuquerque, New Mexico, United States, 87131
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Columbia Univ
New York, New York, United States, 10032
Albany Med College
Albany, New York, United States, 12208
Howard Grossman
New York, New York, United States, 10011
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, United States, 112123198
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
St Vincent's Hosp
New York, New York, United States, 10011
United States, North Carolina
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States, 28207
United States, Ohio
Remington Davis Inc
Columbus, Ohio, United States, 43215
Ian Baird
Columbus, Ohio, United States, 43214
United States, Oklahoma
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pennsylvania State College of Medicine
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States, 02906
United States, Texas
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
Nicholas Bellos
Dallas, Texas, United States, 75246
Thomas Street Clinic
Houston, Texas, United States, 77009
Univ of Texas / Thomas Street Clinic
Houston, Texas, United States, 77030
Dallas Veterans Administration Med Ctr
Dallas, Texas, United States, 75216
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Infectious Diseases Physicians Inc
Annandale, Virginia, United States, 22003
United States, Washington
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, United States, 98405
Infections Ltd PS
Puyallup, Washington, United States, 98371
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico, 009091711
Ponce Univ Hosp
Ponce, Puerto Rico, 00731
San Juan AIDS Program
Santurce, Puerto Rico, 00908

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

Study ID Numbers:	283D, GS-99-907
Study First Received:	January 17, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002450 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
Drug Administration Schedule

RNA, Viral
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on November 27, 2009