The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.

Key facts

Study ID

NCT00002346

Run by

Gilead Sciences

People needed

36

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.
• Patients must have:
• HIV seropositivity.
• CD4 count >= 100 cells/mm3.
• p24 antigen (immune-complex dissociated) >= 50 pg/ml.
• Life expectancy of at least 6 months.
• Prior Medication:
• Allowed:
• Prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
• Malignancy other than cutaneous Kaposi's sarcoma.
• Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
• Gastrointestinal malabsorption syndrome.
• Inability to take oral medication.
• Concurrent Medication:
• Excluded:
• Any parenteral antibiotic therapy.
• Diuretics.
• Amphotericin B.
• Didanosine (ddI).
• Fluconazole.
• Foscarnet.
• Ganciclovir.
• Interferon-alpha.
• Interferon-beta.
• Isoniazid.
• Aminoglycoside antibiotics.
• Ketoconazole (topical allowed).
• Itraconazole.
• Rifabutin.
• Rifampin.
• Stavudine (d4T).

Where it is running

• Johns Hopkins Univ — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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