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Sponsored by: |
Gilead Sciences |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002206 |
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Adefovir dipivoxil |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
Official Title: | A Phase I/II, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 60 Mg Daily Dose of Adefovir Dipivoxil in HIV-Infected Patients Naive to Anti-Retroviral Therapy |
Estimated Enrollment: | 45 |
This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Patients with biopsy-confirmed KS are eligible, but must not have received any systemic therapy (including chemotherapy) for KS within 4 weeks prior to study entry.
1. Antiretroviral therapy, including nucleoside analogues, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational antiretroviral agents (antiretroviral therapy may be started after completion of the Day 35 follow-up visit).
Aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, chemotherapeutic agents (systemic), systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and other investigational agents.
1. Treatment with any HIV protease inhibitor.
Evidence of active substance abuse (including alcohol), as determined by the investigator, that would preclude adequate compliance with the protocol.
United States, District of Columbia | |
Anderson Clinical Research | |
Washington, District of Columbia, United States, 20037 | |
United States, Maryland | |
Johns Hopkins Univ Clinical Pharmacology | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Anderson Clinical Research | |
New York, New York, United States, 10016 | |
United States, Pennsylvania | |
Anderson Clinical Research / Inc | |
Pittsburgh, Pennsylvania, United States, 15213 | |
Anderson Clinical Research | |
Philadelphia, Pennsylvania, United States, 19107 |
Study ID Numbers: | 232F, GS-97-420 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002206 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Adenine Anti-HIV Agents |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Adefovir dipivoxil Retroviridae Infections Adefovir |
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 |