Expired Study
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Seattle, Washington 98122


Purpose:

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.


Study summary:

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


Criteria:

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.


NCT ID:

NCT00002115


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98122
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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