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Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients Clinical research trials and Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients. Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients clinical trial. Participants frequently get the best healthcare available for their Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 600
Location and Contact Information:
Infections Ltd PS
Puyallup, Washington, 98371
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, 90502
United States
Phoenix Body Positive
Phoenix, Arizona, 85016
United States
Remington Davis Inc
Columbus, Ohio, 43215
United States
Regions Hosp / HIV/AIDS Program
St. Paul, Minnesota, 55101
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Howard Grossman
New York City, New York, 10011
United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Dr Joel Gallant
Baltimore, Maryland, 21205
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308
United States
Robert Scott MD
Oakland, California, 94609
United States
Ian Baird
Columbus, Ohio, 43214
United States
Harper Hosp
Detroit, Michigan, 48201
United States
Nicholas Bellos
Dallas, Texas, 75246
United States
St Vincent's Hosp
New York City, New York, 10011
United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
Ponce de Leon Med Ctr
Atlanta, Georgia, 30308
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, 06504
United States
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
United States
Therafirst Med Ctr
Ft. Lauderdale, Florida, 33308
United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
United States
Infectious Diseases Physicians Inc
Annandale, Virginia, 22003
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Pennsylvania State College of Medicine
Hershey, Pennsylvania, 17033
United States
Albany Med College
Albany, New York, 12208
United States
Yale-New Haven Hospital
New Haven, Connecticut, 06504
United States
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Physicans Home Service
Washington D.C., District of Columbia, 20037
United States
Clinical Research Puerto Rico Inc
San Juan, , 009091711
Puerto Rico
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
United States
Kaiser Permanente LAMC
Los Angeles, California, 90027
United States
AIDS Healthcare Foundation-Research Center
Los Angeles, California, 90027
United States
San Juan AIDS Program
Santurce, , 00908
Puerto Rico
New England Med Ctr
Boston, Massachusetts, 02111
United States
Bendel Med Research
Lafayette, Louisiana, 70503
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
St Mary's Med Ctr
Long Beach, California, 90813
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
Columbia Univ
New York City, New York, 10032
United States
ARTCTC
Fort Pierce, Florida, 34950
United States
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681
United States
Thomas Street Clinic
Houston, Texas, 77009
United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
United States
Univ of NM
Albuquerque, New Mexico, 87131
United States
Ponce Univ Hosp
Ponce, , 00731
Puerto Rico
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104
United States
Hillsborough County Health Dept
Tampa, Florida, 33602
United States
Ocean View Internal Medicine
Long Beach, California, 90803
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
San Francisco VA Med Ctr
San Francisco, California, 94121
United States
Additional Information:
Study ID Numbers: 283D; GS-99-907
Study Start Date:
Record last reviewed: July 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002450
Other Hiv Infections Studies:
1. A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia
2. Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
3. The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
4. A Study of Amprenavir in Patients with Protease Inhibitor-Related Complications
5. A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
Related Studies:
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Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
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