Garlic in Hyperlipidemia Caused by HAART

• Status: Withdrawn
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the effectiveness and tolerability of garlic pills in lowering cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are being treated with highly active antiretroviral therapy (HAART).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Allicin

Criteria

Inclusion Criteria:

• HIV-1 seropositive confirmed by medical history

• On stable HAART for at least 6 months before study entry without the likelihood of HAART therapy changes in the following 6 months due to viral rebound or adverse events

• CD4+ lymphocyte number > 100 cells/mm3 measured within 60 days before study entry

• HIV-1 viral load < 2000 RNA copies/ml

• Cholesterol > 200 mg/dL

• Triglycerides > 250 mg/dL < 1000 mg/dL

• Willing and able to avoid raw or dry garlic, onion, leeks and shallots as well as supplements containing garlic during the 16 weeks of the trial

• Willing and able to provide inform consent

• Willing and able to understand and follow protocol for the duration of the study

• Willing and able to maintain a consistent lifestyle routine, eg. diet, exercise, medications, dietary supplements and sleep schedule for the duration of the study

• Willing and able to understand and follow the Step 1 guidelines from the National Cholesterol Education Program (NCEP) for the duration of the study

• Willing to remain adherent to the current HAART regimen