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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002161 |
Purpose
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Adefovir dipivoxil |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3 |
| Estimated Enrollment: | 400 |
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Required:
Required:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Kraus Med Partners | |
| Los Angeles, California, United States, 90509 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94115 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| San Mateo County Med Ctr / San Mateo County AIDS Prog | |
| San Mateo, California, United States, 94403 | |
| Pacific Oaks Research | |
| Sherman Oaks, California, United States, 91403 | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 951282699 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| United States, District of Columbia | |
| Institute for Clinical Research | |
| Washington, District of Columbia, United States, 20422 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Univ of South Florida | |
| St. Petersburg, Florida, United States, 33705 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 303081962 | |
| United States, Illinois | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| Northwestern Univ Med Ctr | |
| Chicago, Illinois, United States, 60611 | |
| United States, Louisiana | |
| Tulane Univ / Tulane / LSU Clinical Trials Unit | |
| New Orleans, Louisiana, United States, 70122 | |
| United States, Massachusetts | |
| Harvard Univ / Massachusetts Gen Hosp | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Wayne State Univ / Univ Health Ctr | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Albany Med College / Clinical Pharmacy Studies | |
| Albany, New York, United States, 12208 | |
| Saint Vincent's Med Ctr | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Oregon | |
| The Research and Education Group | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77004 | |
| Dallas VA Med Ctr | |
| Dallas, Texas, United States, 75216 | |
| Univ of Texas | |
| Galveston, Texas, United States, 77555 | |
| United States, Utah | |
| Univ of Utah School of Medicine | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Wisconsin | |
| Univ of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
More Information
| Study ID Numbers: | 232C, GS-96-408 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002161 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Adenine |
|
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 |