|
Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers Clinical research trials and Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers clinical trial. Subjects frequently obtain the most expert healthcare possible for their Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers  Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
For Condition: Hypertension,Cardiovascular Diseases,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Diltiazem CD and amlodipine are drugs used to treat heart disease and high blood pressure. The purpose of this study is to find out if these drugs interact with the anti-HIV drugs indinavir and ritonavir. The study will also look at the safety of taking the study drugs together. Heart disease and high blood pressure are major health concerns for people with HIV. Standard treatment for these illnesses often includes calcium channel blockers (CCBs). There is a potential for significant drug interactions between CCBs and HIV protease inhibitors (PIs) that may influence the dosing, monitoring, and choosing of CCBs and PIs when used in people infected with HIV. This study will examine the drug interactions between 2 commonly used CCBs and the PI combination indinavir and ritonavir (IDV/RTV). This information should help doctors choose the appropriate treatment for high blood pressure or heart disease in people taking PIs.
Details: Ischemic cardiovascular disease and hypertension occur in persons with HIV infection, and the incidence and prevalence may increase over time as the infected population ages. Standard pharmacologic interventions for these illnesses often include calcium channel blockers (CCBs). Many of the calcium channel blockers are metabolized by cytochrome P450 3A4 (CYP 3A4), which is inhibited by some protease inhibitors (PIs). Thus, there is potential for clinically significant interactions between CCBs and PIs. The presence of significant drug-drug interactions may influence the dosing, monitoring, and choosing of CCBs and/or PIs when used in persons with HIV infection. Because of the potential concomitant use of CCBs with the PI combination IDV/RTV, this study will evaluate bi-directional drug-drug interactions between 2 commonly used CCBs and IDV/RTV. This information should assist clinicians in choosing the appropriate CCBs to treat hypertension or cardiovascular disease in persons taking PIs. Patients are randomized to 1 of the following 2 arms: Arm A: diltiazem CD interaction with IDV and RTV. Arm B: amlodipine interaction with IDV and RTV. From Days 1 to 7, patients take diltiazem CD (Arm A) or amlodipine (Arm B). Plasma is collected for PK over a 24-hour period beginning on Day 7. From Days 8 to 19, patients stop taking their assigned CCB and take IDV and RTV. Plasma is collected for PK over a 12-hour period on Day 19. From Days 20 to 26, patients continue to take IDV and RTV and add diltiazem CD (Arm A) or amlodipine (Arm B). Patients stop all 3 drugs after the last dose on Day 26. Plasma is collected for PK for a 24-hour period beginning on Day 26. Blood work, liver and kidney function tests, urinalysis, and an electrocardiogram (EKG) are performed at some visits.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-negative. - Are between the ages of 18 and 60. - Agree not to become pregnant or to impregnate and to use an acceptable form of contraception while receiving study drugs and for 1 month after stopping study drugs. Patients who are not of reproductive potential are eligible without the contraception requirement. - Are within 30 percent of ideal body weight. - Weigh at least 110 lbs. Exclusion Criteria Patients may not be eligible for this study if they: - Have a history of any illness that requires current medical therapy. - Have a history of any kidney disorder. - Have any medical condition that, in the opinion of the investigator, would interfere with the study. - Are pregnant or breast-feeding. - Use certain drugs within 14 days prior to study entry. - Are allergic or sensitive to study drugs. - Use drugs or alcohol in a way which, in the opinion of the investigator, would interfere with the study. - Have any abnormality on electrocardiogram within 21 days prior to study entry. - Participate in any investigational drug studies within 21 days prior to study entry and during study. - Are unable to participate in pharmacokinetic visits. - Are unable to understand or follow the fluid intake requirement during the periods of IDV/RTV administration.
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
MarshallGlesby, Study Chair,
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Washington Univ (St. Louis)
St. Louis, Missouri, 63108
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: ACTG A5159; AACTG A5159
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039975
Other Cardiovascular Diseases Studies:
1. Pawtucket Heart Health Program
2. Adherence to Antihypertensive Therapy--Data Analyses
3. Suppressed Anger, Blood Pressure and Mortality Follow-up
4. Treatment of Hypertension with Two Exercise Intensities
5. Improving Hypertension Care for Inner City Minorities
Related Studies:
Other Cardiovascular Diseases Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
|
|
|
|
|
|
|
|
