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A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated With Anti-HIV Drugs
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Gilead Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002206
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 45
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV infection, as indicated by a history of seropositivity for HIV-1 infection (ELISA confirmed with Western blot).
  • Peripheral blood CD4 cell count greater than or equal to 150 cells/mm3 on at least 1 measurement within 28 days prior to enrollment.
  • Plasma HIV-1 RNA greater than or equal to 5,000 copies/ml within 28 days of study entry.
  • A minimum life expectancy of 12 months.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Patients should be considered recovered from such infectious episodes when at least 2 weeks have elapsed following the cessation of parenteral antibiotic therapy.
  • Evidence of a gastrointestinal malabsorption syndrome or inability to receive an orally-administered medication.
  • A malignancy other than cutaneous Kaposi's sarcoma (KS). (NOTE:
  • 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).

  • Interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2).
  • 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.

  • Treatment for more than a total of 2 weeks with any nucleoside or nonnucleoside reverse transcriptase inhibitor antiretroviral agent.
  • Ongoing treatment with interferon (alpha, beta, or gamma), interleukins or other immunomodulatory agents, systemic corticosteroids, or any investigational agents except on sponsor's approval within 1 month prior to study entry.

Evidence of active substance abuse (including alcohol), as determined by the investigator, that would preclude adequate compliance with the protocol.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002206

Locations
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
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

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

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Adenine
Anti-HIV Agents

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009