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NCT00017758 · ClinicalTrials.gov registry record · Phase 1

The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs

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

Completed
Registry status
Phase 1
Development phase
56
Enrollment target

NCT00017758: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00017758 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00017758, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

Study Summary

The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz \[EFV\] and nelfinavir \[NFV\]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.

Interventions

  • DRUG Simvastatin
  • DRUG Efavirenz
  • DRUG Nelfinavir mesylate
  • DRUG Atorvastatin calcium
  • DRUG Pravastatin sodium

Trial Details

FieldValue
Enrollment Target 56 participants
Phase Phase 1

What the finished NCT00017758 record still lists

NCT00017758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 5 interventions - of which Simvastatin is the first listed.

NCT00017758 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00017758 about?

NCT00017758 is a clinical study titled "The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs". The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz \[EFV\] and nelfinavir \[NFV\]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increa...

What is the current status of trial NCT00017758?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants.

What interventions are being tested in trial NCT00017758?

The interventions under investigation include: Simvastatin (DRUG), Efavirenz (DRUG), Nelfinavir mesylate (DRUG), Atorvastatin calcium (DRUG), Pravastatin sodium (DRUG).

Who is sponsoring clinical trial NCT00017758?

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 NCT00017758's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 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 NCT00017758, the US trial registry maintained by the National Library of Medicine. NCT00017758 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.