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The Safety and Effectiveness of bis-POM PMEA 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 bis-POM PMEA 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 bis-POM PMEA in HIV-Infected Patients Clinical research trials and The Safety and Effectiveness of bis-POM PMEA 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 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 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 bis-POM PMEA in HIV-Infected Patients clinical trial. Test subjects typically receive the most expert healthcare available for their The Safety and Effectiveness of bis-POM PMEA 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 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 Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
2. Identifying Emergency Room Patients Who Have Recently Been Infected with HIV
3. Treatment of Hepatitis C in Hemophilic Patients with HIV
4. A Study of Viracept in HIV-Positive Women
5. The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
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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