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Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

This study has been completed.

Sponsored by: Gilead Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002128
  Purpose

To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.


Condition Intervention Phase
HIV Infections
Drug: Adefovir dipivoxil
Phase I

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Adefovir dipivoxil    Adefovir    Adenine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Pharmacokinetics Study
Official Title:   Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

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

Estimated Enrollment:   15

Detailed Description:

Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
  • Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).

Patients must have:

  • Documented HIV infection or diagnosis of AIDS.
  • Life expectancy of at least 3 months.

Prior Medication:

Allowed:

  • Prior AZT, ddI, or ddC.
  • Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy.
  • Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
  • Gastrointestinal malabsorption syndrome or inability to receive oral medication.

Concurrent Medication:

Excluded:

  • Diuretics.
  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Parenteral antibiotics.
  • Other nephrotoxic agents.
  • Other investigational agents.
  • Non-steroidal anti-inflammatory drugs.
  • Aspirin.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • Diuretics.
  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Parenteral antibiotics.
  • Other nephrotoxic agents.
  • Other investigational agents.

Excluded within 3 days prior to study entry:

  • Non-steroidal anti-inflammatory drugs.
  • Aspirin. Active substance abuse (including alcohol or drug abuse).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002128

Locations
United States, Maryland
Johns Hopkins Univ    
      Baltimore, Maryland, United States, 21205

Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:

Study ID Numbers:   232A, GS-93-401
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002128
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Antiviral Agents  
Adenine  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Adefovir dipivoxil
AIDS-Related Complex
Adefovir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008




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