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 range19 Years – 75 Years
SexALL
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
…
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