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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Adefovir; Adefovir dipivoxil

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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).

• Zalcitabine (ddC).

• Zidovudine (AZT).

• Lamivudine (3TC).

• Any investigational agents (except with sponsor approval).

• Systemic therapy for Kaposi's sarcoma.

Patients with the following prior condition are excluded:

History of lactose intolerance.

Prior Medication:

Excluded within 2 weeks prior to study entry:

• 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).

• Zalcitabine (ddC).

• Zidovudine (AZT).

• Lamivudine (3TC).

• Any investigational agents (except with sponsor approval).

Excluded within 4 weeks prior to study entry:

Systemic therapy for Kaposi's sarcoma. Active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.