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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.

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

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