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NCT00039975 · ClinicalTrials.gov registry record · Phase 1

Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00039975: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00039975 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00039975, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study 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.

Interventions

  • DRUG Ritonavir
  • DRUG Amlodipine
  • DRUG Indinavir sulfate
  • DRUG Diltiazem HCl

Trial Details

FieldValue
Enrollment Target 32 participants
Est. Completion 2004-04
Phase Phase 1

What the finished NCT00039975 record still lists

NCT00039975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.

NCT00039975 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00039975 about?

NCT00039975 is a clinical study titled "Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers". 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 h...

What is the current status of trial NCT00039975?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. Estimated completion is 2004-04.

What interventions are being tested in trial NCT00039975?

The interventions under investigation include: Ritonavir (DRUG), Amlodipine (DRUG), Indinavir sulfate (DRUG), Diltiazem HCl (DRUG).

Who is sponsoring clinical trial NCT00039975?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00039975's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00039975, the US trial registry maintained by the National Library of Medicine. NCT00039975 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.