Lenalidomide in Kaposi Disease Associated With HIV Infection (NCT01282047) | Clinical Trial Compass
TerminatedPhase 2
Lenalidomide in Kaposi Disease Associated With HIV Infection
France12 participantsStarted 2011-10
Plain-language summary
Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.
Who can participate
Age range
19 Years – 75 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:
* Men or non childbearing (negative serum Human Chorionic Gonadotropin-hCG) non breastfeeding women who practice adequate birth control, maintained 4 weeks after stopping lenalidomide
* Age over 18 years and below 75 years
* Able and willing to give written informed consent
* Serologic documentation of HIV infection by approved tests, undetectable HIV viral load (below 50 copies/mL) independently of CD4 cell counts
* Biopsy proven symptomatic Kaposi sarcoma with at least 4 measurable cutaneous lesions
* Treatment by cART for at least 12 months, without wash out the last 6 months with undetectable HIV-RNA (below 50 copies/mL)
* History of treatment failure or relapse with 1 or more chemotherapy
* Progressive disease with need to new specific therapy
* Wash-out over 4 weeks if previous specific Kaposi sarcoma chemotherapy (8 weeks if Interferon -IFN therapy)
* Karnofsky performance status over 70%
* Social security (State Medical Assistance is not a social security scheme)
* Agree to abstain from donating blood
* Agree not to donate semen
* Agree not to share study drug with another person
Exclusion Criteria:
* Childbearing or breastfeeding (positive betaHCG serum)
* Kaposi sarcoma with only visceral locations
* Kaposi sarcoma with cardiac and/or bronchopulmonary localisations
* 2 viral loads over 50 copies/mL under Highly active antiretroviral therapy (HAART), during the last 6 months
* Opportunistic infections, uncontrolled infections
* Cardiac disease
…
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
1
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
Timeframe: Clinical benefit at week 24
Trial details
NCT IDNCT01282047
SponsorFrench National Agency for Research on AIDS and Viral Hepatitis