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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002426 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Adefovir dipivoxil |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml |
| Estimated Enrollment: | 390 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Contacts and Locations
Hide Study Locations| United States, California | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| Ctr for AIDS Research / Education and Service (CARES) | |
| Sacramento, California, United States, 95814 | |
| San Francisco VA Med Ctr | |
| San Francisco, California, United States, 94121 | |
| ViRx Inc | |
| Palm Springs, California, United States, 92262 | |
| San Francisco Gen Hosp / UCSF AIDS Program | |
| San Francisco, California, United States, 94110 | |
| United States, Connecticut | |
| Blick Med Associates | |
| Stamford, Connecticut, United States, 06901 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Dupont Circle Physicians Group | |
| Washington, District of Columbia, United States, 200091104 | |
| United States, Florida | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Duval County Health Department | |
| Jacksonville, Florida, United States, 32206 | |
| Community AIDS Resource Inc | |
| Coral Gables, Florida, United States, 33146 | |
| Center for Quality Care | |
| Tampa, Florida, United States, 33609 | |
| Health Positive | |
| Safety Harbor, Florida, United States, 34695 | |
| United States, Georgia | |
| Georgia Research Associates | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Infectious Disease Research Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins Univ School of Medicine | |
| Baltimore, Maryland, United States, 21205 | |
| United States, New York | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Albany Med College | |
| Albany, New York, United States, 12208 | |
| St Luke Roosevelt Hosp | |
| New York, New York, United States, 10011 | |
| Bentley-Salick Med Practice | |
| New York, New York, United States, 10011 | |
| James Jones MD | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Wake Forest Univ School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Oklahoma | |
| Associates of Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Oregon | |
| The Research and Education Group | |
| Portland, Oregon, United States, 97210 | |
| United States, Rhode Island | |
| Roger Williams Med Ctr | |
| Providence, Rhode Island, United States, 02908 | |
| Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Tennessee | |
| Vanderbilt Univ School of Medicine | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| United States, Utah | |
| Univ of Utah Med School / Clinical Trials Ctr | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| United States, Washington | |
| N Touch Research Corp | |
| Seattle, Washington, United States, 98122 | |
| Canada, British Columbia | |
| St Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Sunnybrook Health Science Centre | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Centre hospitalier de l'Universite de Montreal (CHUM) | |
| Montreal, Quebec, Canada | |
| France | |
| Hopital Edouard Herriot | |
| Lyon Cedex 03, France | |
| Hopital Sainte-Marguerite | |
| Marseille, France | |
| Germany | |
| Klinikum Der Johann Wolfgang Goethe Universitat | |
| Frankfurt, Germany | |
| Klinikum der Ludwig-Maximilians-Universitaet | |
| Muenchen, Germany | |
| Universitatskrankenhaus Eppendorf | |
| Hamburg, Germany | |
| United Kingdom | |
| Royal Free Hosp | |
| London, United Kingdom | |
| King's College Hospital | |
| London, United Kingdom | |
| Chelsea and Westminster Hosp | |
| London, United Kingdom | |
| Senior Lecturer in GU Medicine | |
| London, United Kingdom | |
More Information
| Study ID Numbers: | 232K, GS-97-415 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002426 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 RNA, Viral VX 478 |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral 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 Adefovir dipivoxil Adefovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
