Clinical trial NCT00002128: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Adenine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univ
state: Maryland
Study officials:
References:
citation: Cundy KC, Barditch-Crovo P, Walker RE, Collier AC, Ebeling D, Toole J, Jaffe HS. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 1995 Nov;39(11):2401-5. doi: 10.1128/AAC.39.11.2401.