Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-infected Patients in Virological … (NCT00196625) | Clinical Trial Compass
CompletedPhase 2
Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-infected Patients in Virological Failure.
France100 participantsStarted 2000-11
Plain-language summary
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.
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:
* Documented HIV infection
* CD4 cell count below 300/mm3
* Plasma HIV RNA over 30,000 copies/ml
* Previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir)
* Written informed consent
Exclusion Criteria:
* Biological abnormalities
* Pregnancy
* Alcool abuse
* History of pancreatitis, hepatic failure
* Acute HIV related infection
* Chemotherapy
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.
1This is a Phase 2 salvage therapy trial using amprenavir, lopinavir, and ritonavir together — what does it mean that it's a Phase 2 study when it comes to how much is already known about whether this combination is safe and effective for someone in my situation?
2Since this trial was designed for people who are already in virological failure on their current HIV treatment, how would you determine whether my current situation matches what the trial was looking for, and is salvage therapy the right next step for me?
3The trial measured changes in HIV RNA levels over 26 weeks — based on the results that came out of this completed study, did the combination of amprenavir, lopinavir, and ritonavir actually show meaningful viral suppression, and how does that compare to other salvage options available to me now?
4Using three antiretroviral drugs together — amprenavir, lopinavir, and ritonavir — sounds like an intensive regimen; what kinds of side effects or drug interactions were seen, and how might those affect my day-to-day life?
5Since this trial is already completed, are its findings being used to guide current treatment decisions, or are there newer salvage therapy approaches you'd recommend exploring instead?
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.