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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Adefovir dipivoxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002346

GS-93-402

232B

Details and patient eligibility

About

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.

Full description

Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.