Expired Study
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Bethesda, Maryland 20892


Purpose:

To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination zidovudine (AZT) and PMEA (adefovir) therapy.


Study summary:

Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will be defined for this regimen.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable regimen for at least 4 weeks prior to study entry. Patients must have: - HIV seropositivity. - Mean CD4 count <= 500 cells/mm3. - Been receiving AZT at 500 mg daily for at least 4 weeks prior to study entry. - Life expectancy of at least 3 months. NOTE: - Kaposi's sarcoma is permitted provided patient has not received any systemic therapy for KS within the past 4 weeks. Patients with a history of another malignancy must be disease free for 6 months or more prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Inadequate venous access. - Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. - Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or clinically significant arrhythmia. - Active malignancy other than Kaposi's sarcoma. - Mental incapacity or illness that may affect compliance. Concurrent Medication: Excluded: - ddI or ddC. - Interferon alpha. - Ganciclovir. - Foscarnet. - Diuretics. - Investigational agents including d4T. - Chemotherapeutic agents. - Amphotericin B. - Aminoglycoside antibiotics. - Other nephrotoxic agents. - Immunomodulatory agents. - Parenteral therapy for an active, serious infection (other than HIV infection). Prior Medication: Excluded within 2 weeks prior to study entry: - ddI or ddC. - Interferon alpha. - Ganciclovir. - Foscarnet. - Diuretics. - Investigational agents including d4T. - Chemotherapeutic agents. - Amphotericin B. - Aminoglycoside antibiotics. - Other nephrotoxic agents. - Immunomodulatory agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Required: - AZT at a stable dose for at least 4 weeks prior to study entry. Current use of illicit drugs (e.g., heroin or cocaine). Ingestion of substantial alcohol.


NCT ID:

NCT00002326


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
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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