Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Amlodipine; Calcium Channel Blockers; Calcium, Dietary; Diltiazem; HIV Protease Inhibitors; Indinavir; Protease Inhibitors; Ritonavir

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.