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Alternative Dosing Strategy for 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 using a real mD. We aren't mDs. Always confer with your physician on Alternative Dosing Strategy for Anti-HIV Drugs conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Alternative Dosing Strategy for Anti-HIV Drugs Clinical research trials and Alternative Dosing Strategy for Anti-HIV Drugs 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 Alternative Dosing Strategy for Anti-HIV Drugs. Alternative Dosing Strategy for Anti-HIV Drugs 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 Alternative Dosing Strategy for Anti-HIV Drugs clinical trial. Human subjects often receive the most effective healthcare possible for their Alternative Dosing Strategy for Anti-HIV Drugs 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 > "A" Clinical Trials Conditions > Alternative Dosing Strategy for Anti-HIV Drugs  Alternative Dosing Strategy for Anti-HIV Drugs
Alternative Dosing Strategy for Anti-HIV Drugs
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Anti-HIV drugs are usually given to patients at fixed, standardized doses. This study will investigate alternative ways of dosing anti-HIV drugs to improve viral control.
Details: While optimism for the benefits of antiretroviral therapy remain justified, the response to therapy varies widely. This variability arises because of differences among patients in virologic, immunologic, behavioral, and pharmacologic factors, all of which impact therapeutic success. Antiretroviral agents are presently administered to adults in standard fixed doses. However, the same dose does not produce the same systemic and intracellular concentrations in all patients. Recent research has shown that adjusting the doses of antiretroviral agents to achieve target concentrations in plasma is associated with an improved anti-HIV response compared with standard dose therapy. This study will extend the paradigm of concentration-controlled therapy to develop intensified pharmacologic regimens for patients experiencing persistent viremia while receiving antiretroviral therapy. Two approaches will be investigated: 1) a regimen that targets concentrations of each antiretroviral drug between the 50th and 75th percentile of expected concentrations in adults; and 2) a novel regimen in which the target concentrations are based upon a desired ratio between phenotypic drug susceptibility (IC90) and the concentrations of pharmacologically active moieties, specifically intracellular nucleoside triphosphates and unbound protease and nonnucleoside inhibitors. Participants will be randomized to either one of the investigational approaches (Cohort II) or to a control group receiving standard dose therapy (Cohort I). There are two study visits in the first month; after the first month, study visits are scheduled monthly for five additional months. Study visits include laboratory tests of virologic and immunologic parameters, pharmacokinetic sampling, and adherence counseling and monitoring.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Cohort I: - HIV infected - Receiving therapy with 3 or more antiretroviral medications and and willing to continue this regimen - Achieved a greater than 1 log10 reduction in plasma HIV-RNA from baseline within 8 weeks after the start of current therapy - Current plasma HIV-RNA levels greater than 500 copies/mL and less than 10,000 copies/mL Inclusion Criteria for Cohort Cohort II: - HIV infected - Receiving antiretroviral therapy and have been determined to have had virologic failure - Will or have been changed to a new antiretroviral regimen (addition of greater than one new antiretroviral agent), but have not received this new regimen for more than 4 weeks as of study entry - HIV RNA of 2500 copies/mL or greater at screening Exclusion Criteria - Concurrent investigational antiretroviral agent - Malignancy, including Kaposi's sarcoma, requiring systemic chemotherapy - Active opportunistic infection requiring therapy within 14 days prior to study entry - Drug-resistant mutations that necessitate a change in antiretroviral regimen - Active drug or alcohol use or dependence - Certain laboratory abnormalities - Pregnant or breastfeeding - Known nonadherence with medications and scheduled clinic visits - Any medical condition that, in the opinion of the investigators, would preclude successful completion of the study
Total Enrollment: 66
Location and Contact Information:
Overall Study Official:
CourtneyFletcher, Principal Investigator, University of Colorado
University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Courtney Fletcher 303-315-5229
Additional Information:
Study ID Numbers: 2R01AI33835-08A1; 3M01RR000400-34S1A20420Ăș,5M01RR000400-340420
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059384
Other Hiv Infections Studies:
1. A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
2. A 14-day study of Racivir when used in combination in HIV-Infected Males
3. A Study of GENEVAX-HIV, a Possible Vaccine
4. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
5. Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Related Studies:
Other HIV Infections Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Alternative Dosing Strategy for Anti-HIV Drugs
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