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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.
Study NCT00002128.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief 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
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
Brief Summary

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.

Detailed Description

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

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Dose Comparison, Pharmacokinetics Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Adefovir dipivoxil
MEDLINE PMIDs 8585716
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  15
Start Date 
Completion Date
Eligibility 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).
Gender Both
Ages 18 Years to 60 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002128
Organization ID 232A
Secondary IDs †† GS-93-401
Study Sponsor  Gilead Sciences
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date July 1994
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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