Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
Evaluation of Potential Pharmacokinetic Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
4 other identifiers
interventional
32
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2002
CompletedFirst Posted
Study publicly available on registry
June 20, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedNovember 1, 2021
October 1, 2021
June 18, 2002
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Univ of California San Francisco
San Francisco, California, 94110, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington Univ (St. Louis)
St Louis, Missouri, 63108, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Related Publications (5)
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.
PMID: 9637579BACKGROUNDHenry 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.
PMID: 9643798BACKGROUNDCattelan 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.
PMID: 11371700BACKGROUNDPassalaris 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.
PMID: 11017831BACKGROUNDGlesby 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.
PMID: 16084849RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marshall Glesby
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2002
First Posted
June 20, 2002
Study Completion
April 1, 2004
Last Updated
November 1, 2021
Record last verified: 2021-10