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Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients Clinical research trials and Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients  Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
Details: Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.
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: - AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). - Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Patients must have: - Documented HIV infection or diagnosis of AIDS. - Life expectancy of at least 3 months. Prior Medication: Allowed: - Prior AZT, ddI, or ddC. - Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy. - Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. - Gastrointestinal malabsorption syndrome or inability to receive oral medication. Concurrent Medication: Excluded: - Diuretics. - Amphotericin B. - Aminoglycoside antibiotics. - Parenteral antibiotics. - Other nephrotoxic agents. - Other investigational agents. - Non-steroidal anti-inflammatory drugs. - Aspirin. Prior Medication: Excluded within 2 weeks prior to study entry: - Diuretics. - Amphotericin B. - Aminoglycoside antibiotics. - Parenteral antibiotics. - Other nephrotoxic agents. - Other investigational agents. Excluded within 3 days prior to study entry: - Non-steroidal anti-inflammatory drugs. - Aspirin. Active substance abuse (including alcohol or drug abuse).
Total Enrollment: 15
Location and Contact Information:
Johns Hopkins Univ
Baltimore, Maryland, 21205
United States
Additional Information:
Study ID Numbers: 232A; GS-93-401
Study Start Date:
Record last reviewed: July 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002128
Other Hiv Infections Studies:
1. Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons with Drug Resistance
2. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
3. A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients
4. Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults
5. A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
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Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
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