Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
NCT ID: NCT00039975
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Indinavir sulfate
Ritonavir
Amlodipine
Diltiazem HCl
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Marshall Glesby
Role: STUDY_CHAIR
Locations
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Univ of California San Francisco
San Francisco, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Washington Univ (St. Louis)
St Louis, Missouri, United States
Cornell Univ Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Countries
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References
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Yunis NA, Stone VE. Cardiac manifestations of HIV/AIDS: a review of disease spectrum and clinical management. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Jun 1;18(2):145-54. doi: 10.1097/00042560-199806010-00006.
Henry K, Melroe H, Huebsch J, Hermundson J, Levine C, Swensen L, Daley J. Severe premature coronary artery disease with protease inhibitors. Lancet. 1998 May 2;351(9112):1328. doi: 10.1016/S0140-6736(05)79053-X. No abstract available.
Cattelan AM, Trevenzoli M, Sasset L, Rinaldi L, Balasso V, Cadrobbi P. Indinavir and systemic hypertension. AIDS. 2001 Apr 13;15(6):805-7. doi: 10.1097/00002030-200104130-00021. No abstract available.
Passalaris JD, Sepkowitz KA, Glesby MJ. Coronary artery disease and human immunodeficiency virus infection. Clin Infect Dis. 2000 Sep;31(3):787-97. doi: 10.1086/313995. Epub 2000 Oct 4.
Glesby MJ, Aberg JA, Kendall MA, Fichtenbaum CJ, Hafner R, Hall S, Grosskopf N, Zolopa AR, Gerber JG; Adult AIDS Clinical Trials Group A5159 Protocol Team. Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers. Clin Pharmacol Ther. 2005 Aug;78(2):143-53. doi: 10.1016/j.clpt.2005.04.005.
Other Identifiers
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10959
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5159
Identifier Type: -
Identifier Source: secondary_id
AACTG A5159
Identifier Type: -
Identifier Source: secondary_id
A5159
Identifier Type: -
Identifier Source: org_study_id