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

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Gilead Sciences

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Adefovir dipivoxil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002128
232A
GS-93-401

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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