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The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients Clinical research trials and The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients. The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients clinical trial. Human subjects often receive the most effective healthcare possible for their The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients  The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients
The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.
Details: Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry. Patients must have: - HIV seropositivity. - CD4 count >= 100 cells/mm3. - p24 antigen (immune-complex dissociated) >= 50 pg/ml. - Life expectancy of at least 6 months. Prior Medication: Allowed: - Prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy. - Malignancy other than cutaneous Kaposi's sarcoma. - Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. - Gastrointestinal malabsorption syndrome. - Inability to take oral medication. Concurrent Medication: Excluded: - Any parenteral antibiotic therapy. - Diuretics. - Amphotericin B. - Didanosine (ddI). - Fluconazole. - Foscarnet. - Ganciclovir. - Interferon-alpha. - Interferon-beta. - Isoniazid. - Aminoglycoside antibiotics. - Ketoconazole (topical allowed). - Itraconazole. - Rifabutin. - Rifampin. - Stavudine (d4T). - Zalcitabine (ddC). - Zidovudine (AZT). - Lamivudine (3TC). - Any investigational agents (except with sponsor approval). - Systemic therapy for Kaposi's sarcoma. Patients with the following prior condition are excluded: History of lactose intolerance. Prior Medication: Excluded within 2 weeks prior to study entry: - Any parenteral antibiotic therapy. - Diuretics. - Amphotericin B. - Didanosine (ddI). - Fluconazole. - Foscarnet. - Ganciclovir. - Interferon-alpha. - Interferon-beta. - Isoniazid. - Aminoglycoside antibiotics. - Ketoconazole (topical allowed). - Itraconazole. - Rifabutin. - Rifampin. - Stavudine (d4T). - Zalcitabine (ddC). - Zidovudine (AZT). - Lamivudine (3TC). - Any investigational agents (except with sponsor approval). Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.
Total Enrollment: 36
Location and Contact Information:
Johns Hopkins Univ
Baltimore, Maryland, 21205
United States
Additional Information:
Study ID Numbers: 232B; GS-93-402
Study Start Date:
Record last reviewed: March 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002346
Other Hiv Infections Studies:
1. A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
2. Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
3. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia in AIDS
4. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
5. Study of Itraconazole in Patients with Advanced HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
The Safety and Effectiveness of bis-POM PMEA in HIV-Infected Patients
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