CompletedPhase 4

Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)

France86 participantsStarted 2005-10

Plain-language summary

In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Fasting LDL cholesterol over 4.1 mmol/L (1.6 g/l) * Blood triglycerides over 8.8 mmol/L (8 g/l) * HIV-1 infection * Viral load above or equal to 10.000 copies/ml * Stable antiretroviral regimen for past two months Exclusion Criteria: * Coronary disease * Genetic muscular disease * CPK over 5N * Hepatic or renal insufficiency * Alcohol intake more than 40g/d * Hypothyroidism * Pregnancy and breast feeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor on D45.

Trial details

NCT IDNCT00117494

SponsorFrench National Agency for Research on AIDS and Viral Hepatitis

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2007-03

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