The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
NCT ID: NCT00002326
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Adefovir
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Locations
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Natl Cancer Institute
Bethesda, Maryland, United States
Countries
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Other Identifiers
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GS-93-204
Identifier Type: -
Identifier Source: secondary_id
217B
Identifier Type: -
Identifier Source: org_study_id