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The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients Clinical research trials and The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients. The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients clinical trial. Test subjects typically receive the most expert healthcare available for their The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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. A Study of the Side Effects of L-743,872 in Men with Candidal Esophagitis
2. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3
3. A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
4. The Treatment of Tuberculosis in HIV-Infected Patients
5. Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)
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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