The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
2 other identifiers
interventional
56
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2006
February 1, 2004
June 11, 2001
March 13, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Volunteers may be eligible for this study if they:
- Are HIV-negative.
- Are 18 to 60 years old.
- Weigh at least 50 kg (110 lbs) and are within 30 percent of their ideal body weight.
- Cannot have children (have reached menopause \[change of life\] for at least 24 straight months or have had a hysterectomy), if female and enrolling to Group A, B, or C.
- Have a negative pregnancy test within 14 days before study entry and within 24 hours before starting the study drugs, if female, able to have children, and enrolling to Group D.
- Agree to avoid trying to become pregnant or causing someone to become pregnant. Agree not to donate sperm or participate in other fertilization procedures. If participating in sexual activity that could lead to pregnancy, the study volunteer and/or partner must use 2 reliable methods of birth control at the same time, while taking study drugs, and for 6 weeks after stopping the drugs. Male volunteers are allowed to be sexually active without the use of birth control if they have had a successful vasectomy or are sterile.
You may not qualify if:
- Volunteers will not be eligible for this study if they:
- Have or have had heart, kidney, blood, nerve, digestive, mental, hormonal, or immune system diseases. These include high blood pressure, blocked arteries, arthritis, diabetes, stomach or intestinal problems, depression, and past use of antidepressant drugs.
- Are pregnant or breast-feeding.
- Have used experimental, prescription, or over-the-counter drugs within 14 days before study entry, except for aspirin (ASA), acetaminophen (Tylenol), diphenhydramine (Benadryl), daily multivitamins, mineral supplements, birth control pills or implants, and hormone replacement therapy for women who have reached menopause.
- Are allergic to study drugs or their ingredients.
- Abuse drugs or alcohol.
- Have a medical condition that, in the opinion of the investigator, would interfere with their participation in the study.
- Have participated in any experimental drug study within 30 days before study entry.
- Are not able to keep their usual diet during the study or are unable to write down their food intake before the study visits.
- Have an abnormal urine test result, e.g., urinary tract infection, kidney disease, or kidney stones.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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 Connect Care
St Louis, Missouri, 63108, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Aberg JA, Rosenkranz SL, Fichtenbaum CJ, Alston BL, Brobst SW, Segal Y, Gerber JG; ACTG A5108 team. Pharmacokinetic interaction between nelfinavir and pravastatin in HIV-seronegative volunteers: ACTG Study A5108. AIDS. 2006 Mar 21;20(5):725-9. doi: 10.1097/01.aids.0000216373.53819.92.
PMID: 16514303RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Gerber
- STUDY CHAIR
Judith Aberg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 11, 2001
First Posted
August 31, 2001
Last Updated
March 14, 2006
Record last verified: 2004-02