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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo in HIV-Infected Patients

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Adefovir dipivoxil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adefovir dipivoxil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents