|
A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood Clinical research trials and A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood. A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood  A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood
A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.
Details: Potent antiretroviral therapy has become the standard of care for persons with HIV infection and AIDS. Recently, however, a number of complications have emerged with the widespread use of protease inhibitor (PI)-based regimens, including: hyperlipidemia, hypertriglyceridemia, diabetes mellitus, and lipodystrophy. Concern over the possibility of premature myocardial infarction has led health care providers and patients to consider treating these lipid metabolism disorders. Statin compounds have beneficial effects as lipid-lowering agents, and thereby reduce the risk of cardiovascular complications. Statin compounds such as pravastatin, simvastatin, and atorvastatin are increasingly being prescribed in persons taking PI-based potent antiretroviral therapy. It is important to determine whether there are significant drug-drug interactions between the statin compounds and PIs. Fourteen healthy participants for each cohort of Arm A are stabilized on a fixed regimen of pravastatin (Arm A1), simvastatin (Arm A2), or atorvastatin (Arm A3) for 4 days. A baseline pharmacokinetic (PK) evaluation is completed on Day 4. Pravastatin (or simvastatin or atorvastatin) dosing stops following the Day 4 dose and PK evaluation. On Day 5, a ritonavir and saquinavir combination regimen is initiated and continued through Day 18 of the study. Pravastatin (or simvastatin or atorvastatin) dosing resumes on Day 15 and continues through Day 18. A repeat PK evaluation of pravastatin (or simvastatin or atorvastatin) in the context of combination therapy is carried out on Day 18. Fourteen healthy participants are assigned to Arm B; these participants begin a 2-week regimen of nelfinavir. On Day 14, a baseline PK profile of nelfinavir and its M8 metabolite is carried out. Pravastatin is then added to the regimen for Days 15 to 18. On Day 18, a repeat PK evaluation of nelfinavir and the M8 metabolite is carried out in the context of combination therapy.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-negative. - Are between the ages of 18 and 60. - Agree to use a barrier method of birth control (e.g., a condom) during the study. Exclusion Criteria You will not be eligible for this study if you: - Have a history of a chronic illness such as high blood pressure, heart disease, arthritis, or diabetes. - Are pregnant or breast-feeding. - Are taking certain medications.
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
FrancescaAweeka, Study Chair,
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of Washington
Seattle, Washington, 98104
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Additional Information:
Study ID Numbers: ACTG A5047;
Study Start Date: September 1998
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000941
Other Hiv Infections Studies:
1. Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas
2. Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces boulardii or Placebo: A Double Blind Trial
3. A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination with Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment with GLQ223 or Trichosanthin
4. A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients
5. A Randomized Trial of the Efficacy and Safety of a Strategy of Starting with Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals with CD4+ Cell Counts Less than or Equal to 200/mm3
Related Studies:
Other HIV Infections Clinical Trials
Other South Carolina Clinical Trials
Other West Columbia Clinical Trials
A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood
|
|
|
|
|
|
|
|
