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

Launched by GILEAD SCIENCES · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.