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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients Clinical research trials and A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients. A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients clinical trial. Participants frequently obtain the most expert healthcare available for their A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients
A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 390
Location and Contact Information:
Albany Med College
Albany, New York, 12208
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, 27157
United States
San Francisco VA Med Ctr
San Francisco, California, 94121
United States
King's College Hospital
London, ,
United Kingdom
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Chelsea and Westminster Hosp
London, ,
United Kingdom
James Jones MD
New York City, New York, 10019
United States
Royal Free Hosp
London, ,
United Kingdom
Thomas Street Clinic
Houston, Texas, 77009
United States
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110
United States
Pacific Oaks Research
Beverly Hills, California, 90211
United States
Universitatskrankenhaus Eppendorf
Hamburg, ,
Germany
Health Positive
Safety Harbor, Florida, 34695
United States
Georgia Research Associates
Atlanta, Georgia, 30342
United States
Senior Lecturer in GU Medicine
London, ,
United Kingdom
TheraFirst Med Ctrs Inc
Ft. Lauderdale, Florida, 33308
United States
Univ of Texas Med Branch
Galveston, Texas, 77555
United States
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212
United States
Center for Quality Care
Tampa, Florida, 33609
United States
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, ,
Germany
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
ViRx Inc
Palm Springs, California, 92262
United States
Miriam Hosp
Providence, Rhode Island, 02906
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Hopital Sainte-Marguerite
Marseille, ,
France
Duval County Health Department
Jacksonville, Florida, 32206
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Sunnybrook Health Science Centre
Toronto, Ontario,
Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec,
Canada
Roger Williams Med Ctr
Providence, Rhode Island, 02908
United States
Associates of Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
United States
N Touch Research Corp
Seattle, Washington, 98122
United States
Bentley-Salick Med Practice
New York City, New York, 10011
United States
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, 84108
United States
St Paul's Hosp
Vancouver, British Columbia,
Canada
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814
United States
St Luke Roosevelt Hosp
New York City, New York, 10011
United States
Hopital Edouard Herriot
Lyon Cedex 03, ,
France
Community AIDS Resource Inc
Coral Gables, Florida, 33146
United States
Klinikum der Ludwig-Maximilians-Universitaet
Muenchen, ,
Germany
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Blick Med Associates
Stamford, Connecticut, 06901
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Additional Information:
Study ID Numbers: 232K; GS-97-415
Study Start Date:
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002426
Other Hiv Infections Studies:
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2. A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS
3. A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
4. The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
5. A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
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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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