Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT00006412
• Date of registration: 13/10/2000
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids
• Scientific title: A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities
• Date of first enrolment: October 25, 2000
• Target sample size: 630
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00006412
• Study type: Interventional
• Study design: Primary purpose: Treatment.
• Phase: Phase 3

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: Judith Aberg

Key inclusion & exclusion criteria

Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive.

- Are at least 18 years old.

- Are on a lipid-lowering diet based on the patient's statement and have been exercising
for at least 30 days before being screened for the study. Patients will be asked if
they were counseled by their health care provider. The lipid-lowering diet and
exercise program do not have to be prescribed by a physician.

- Have a triglyceride (TG) level of at least 200 mg/dl and low-density lipoprotein (LDL)
level of at least 130 mg/dl after fasting for 8 to 12 hours.

- Have been treated with anti-HIV drugs for more than 6 months. Patients must be taking
the anti-HIV drugs regularly for at least 4 weeks before they enter the study.
Patients must be taking anti-HIV drugs regularly for at least 8 weeks if they have
changed from taking protease inhibitor (PI) anti-HIV drugs to non-PI anti-HIV drugs.
Any combination without a PI must lower the patient's HIV viral levels, as determined
by the patient's physician.

- Are willing, if able to become pregnant, to use 2 reliable types of birth control
while taking the study drug(s) and for 1 month after stopping the drug(s).

- Have a negative pregnancy test.

- (This reflects a change in inclusion requirements.)

Exclusion Criteria

Patients will not be eligible for the study if they:

- Have a history of heart disease.

- Have uncontrolled high blood pressure within 4 weeks of study entry.

- Have liver disease.

- Have gall bladder disease or symptoms within 3 months prior to study entry or symptoms
of gallstones.

- Had surgery to remove their gallbladder within 3 months prior to study entry.

- Have diabetes requiring drug treatment or diabetes not controlled by diet.

- Have hypothyroidism (low thyroid activity).

- Are allergic or sensitive to the study drug(s) or to other lipid-lowering drugs.

- Have rhabdomyolysis (a muscle disease).

- Have taken any prescription or non-prescription lipid-lowering drug within 14 days
prior to study entry or for over 24 weeks in the past.

- Take prescription lipid-lowering agents, other than those given by the study, and
non-prescription lipid-lowering agents such as garlic supplements.

- Have failed previous statin or fibrate therapy (after 24 weeks of treatment) or have
had side effects from these drugs.

- Receive or have received (within 14 days of study entry) treatment not approved by the
FDA. Anti-HIV medications and immune-based treatments not approved by the FDA may be
allowed on a case-by-case basis with the approval of the protocol team.

- Were given systemic chemotherapy for cancer other than Kaposi's sarcoma (KS).

- Were given radiation therapy within 30 days of study entry.

- Take drugs that increase risk of muscle disease (such as cyclosporine, erythromycin,
itraconazole, and ketoconazole), within 14 days of study entry.

- Take or have taken levothyroxine and liothyronine for hypothyroidism.

- Take high doses of testosterone.

- Take creatine monophosphate or drugs that affect the immune system, within 30 days of
study entry.

- Abuse drugs or alcohol, and the doctor thinks this may interfere with the study.

- Are pregnant or breast-feeding.

- Had a scheduled anti-HIV treatment withdrawal prior to study entry.

- (This reflects a change in exclusion requirements.)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lipodystrophy

HIV Infections

Intervention(s)

Drug: Fenofibrate

Drug: Pravastatin sodium

Secondary ID(s)

AACTG A5087

A5087

ACTG A5087

10917

Source(s) of Monetary Support

Please refer to primary and secondary sponsors