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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00017758
• Date of registration: 11/06/2001
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
• Scientific title: The Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylglutaryl Coenzyme A Reductase Inhibitors
• Date of first enrolment: June 2001
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00017758
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: John Gerber

• Name: Judith Aberg

Key inclusion & exclusion criteria

Inclusion Criteria

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.

Exclusion Criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Seronegativity

HIV Infections

Lipodystrophy

Intervention(s)

Drug: Atorvastatin calcium

Drug: Nelfinavir mesylate

Drug: Pravastatin sodium

Drug: Efavirenz

Drug: Simvastatin

Secondary ID(s)

AACTG A5108

ACTG A5108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors