A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Study Overview
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Brief Summary
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To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.

Detailed Description
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Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.

Official Title
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A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Adefovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Concurrent Medication: Allowed: Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry. Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry. Patients must have: HIV seropositivity. Elevated p24 antigen (> 40 pg/ml). Mean CD4 count <= 100 cells/mm3. Life expectancy of at least 3 months. Prior Medication: Allowed: Other prior antiretroviral therapy. Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inadequate venous access. Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Psychiatric disturbance or illness that may affect compliance. Malignancy other than Kaposi's sarcoma. Concurrent Medication: Excluded: Investigational agents other than stavudine (d4T). Interferon-alpha. Ganciclovir. Foscarnet. Diuretics. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Acyclovir at doses >= 2 g/day. Prior Medication: Excluded within 2 weeks prior to study entry: Investigational agents other than stavudine (d4T). Interferon-alpha. Ganciclovir. Foscarnet. Diuretics. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Substance abuse.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adefovir|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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Acquired Immunodeficiency Syndrome, Antiviral Agents, Adenine