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A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs Clinical research trials and A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs. A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs clinical trial. Test subjects typically receive the most effective healthcare possible for their A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs  A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs
A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil.
Details: This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection, as indicated by a history of seropositivity for HIV-1 infection (ELISA confirmed with Western blot). - Peripheral blood CD4 cell count greater than or equal to 150 cells/mm3 on at least 1 measurement within 28 days prior to enrollment. - Plasma HIV-1 RNA greater than or equal to 5,000 copies/ml within 28 days of study entry. - A minimum life expectancy of 12 months. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Patients should be considered recovered from such infectious episodes when at least 2 weeks have elapsed following the cessation of parenteral antibiotic therapy. - Evidence of a gastrointestinal malabsorption syndrome or inability to receive an orally-administered medication. - A malignancy other than cutaneous Kaposi's sarcoma (KS). (NOTE: - Patients with biopsy-confirmed KS are eligible, but must not have received any systemic therapy (including chemotherapy) for KS within 4 weeks prior to study entry. 1. Antiretroviral therapy, including nucleoside analogues, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational antiretroviral agents (antiretroviral therapy may be started after completion of the Day 35 follow-up visit). - Interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2). - Aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, chemotherapeutic agents (systemic), systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and other investigational agents. 1. Treatment with any HIV protease inhibitor. - Treatment for more than a total of 2 weeks with any nucleoside or nonnucleoside reverse transcriptase inhibitor antiretroviral agent. - Ongoing treatment with interferon (alpha, beta, or gamma), interleukins or other immunomodulatory agents, systemic corticosteroids, or any investigational agents except on sponsor's approval within 1 month prior to study entry. Evidence of active substance abuse (including alcohol), as determined by the investigator, that would preclude adequate compliance with the protocol.
Total Enrollment: 45
Location and Contact Information:
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213
United States
Anderson Clinical Research
Philadelphia, Pennsylvania, 19107
United States
Anderson Clinical Research
New York City, New York, 10016
United States
Anderson Clinical Research
Washington D.C., District of Columbia, 20037
United States
Johns Hopkins Univ Clinical Pharmacology
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: 232F; GS-97-420
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002206
Other Hiv Infections Studies:
1. Phase III PEG-Intron in HIV-infected patients
2. Follow-up Protocol for Patients with Cancer/AIDS/Skin Disease
3. Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
4. Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
5. Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated with Anti-HIV Drugs
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