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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients  The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination zidovudine (AZT) and PMEA (adefovir) therapy.
Details: Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will be defined for this regimen.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 20
Location and Contact Information:
Natl Cancer Institute
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 217B; GS-93-204
Study Start Date:
Record last reviewed: October 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002326
Other Hiv Infections Studies:
1. Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
2. Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
3. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
4. A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
5. A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
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