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A 14-day study of Racivir when used in combination in HIV-Infected Males 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 A 14-day study of Racivir when used in combination in HIV-Infected Males conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A 14-day study of Racivir when used in combination in HIV-Infected Males Clinical research trials and A 14-day study of Racivir when used in combination in HIV-Infected Males 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 A 14-day study of Racivir when used in combination in HIV-Infected Males. A 14-day study of Racivir when used in combination in HIV-Infected Males 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 A 14-day study of Racivir when used in combination in HIV-Infected Males clinical trial. Participants oftentimes recieve the most expert healthcare available for their A 14-day study of Racivir when used in combination in HIV-Infected Males 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 > "A" Clinical Trials Conditions > A 14-day study of Racivir when used in combination in HIV-Infected Males  A 14-day study of Racivir when used in combination in HIV-Infected Males
A 14-day study of Racivir when used in combination in HIV-Infected Males
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Pharmasset ,
Synopsis: The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.
Details: The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Subjects may be eligible to participate if they: - Are males with HIV infection with a positive HIV antibody test - Have an HIV-RNA copy number of 5000 copies/ml (Roche assay) - Have CD4+ cell counts 50 cells/ml - Are 18-45 years of age, inclusive - Have a body mass index (BMI) 18 kg/m2 - Are antiretroviral nucleoside reverse transcriptase inhibitor-naive - Have read and understand the informed consent,and is able and willing to comply with study procedures Exclusion Criteria Subjects may not participate if they: - Have clinically significant ECG abnormalities - Have clinically significant abnormalities in any safety laboratory parameters - Have an ALT value 3xUNL - Have previously participated in this trial - Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug - Have a history of chronic alcohol or drug abuse within the last 6 months - Have a positive urine drug screening - Have a positive alcohol breath test - Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject’s ability to participate in this trial - Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol
Total Enrollment: 18
Location and Contact Information:
3ClinicalResearch *Recruiting*
Berlin, ,
Germany
Recruiting Amanda Beard
Additional Information:
Study ID Numbers: CI-PSI-004-02-101;
Study Start Date: June 2002
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040300
Other Hiv Infections Studies:
1. A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients
2. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
3. A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
4. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
5. A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients
Related Studies:
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A 14-day study of Racivir when used in combination in HIV-Infected Males
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