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A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. Clinical research trials and A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.. A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. clinical trial. Participants oftentimes recieve the finest healthcare available for their A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease. condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.  A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.
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: - 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.
Total Enrollment: 20
Location and Contact Information:
Univ of Washington
Seattle, Washington, 98122
United States
Additional Information:
Study ID Numbers: 217A; GS-92-202
Study Start Date:
Record last reviewed: November 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002115
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A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
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