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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002128
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1994
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00002128     History of Changes
Other Study ID Numbers: 232A, GS-93-401
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Adefovir
Adefovir dipivoxil
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014