HIV Infection Associated Kaposi DiseasePhase 2LENAKAPNCT01282047
Lenalidomide in Kaposi Disease Associated With HIV Infection
A Phase 2 study testing Lenalidomide in people with HIV Infection Associated Kaposi Disease, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- HIV Infection Associated Kaposi Disease
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- Castleman disease or lymphoma
- Other cancers or previous or current haematological malignancies
- Polyneuritis, grade over 2
- Association with neurotoxic drugs such as isoniazid, d4T
- Neutrophil polynuclear count below 1000/mm3 or platelets below 75000/mm3
- Life expectation under 2 months
- Creatinine clearance below or equal 50 mL/min (Cockcroft-Gault formula)
- Serum Glutamopyruvate Transferase (SGPT) or Serum Glutamooxaloacetate Transferase (SGOT) over or equal 3
- Concomitant treatment with antineoplastic drugs
- Known allergy or hypersensitivity to aspirin, to lenalidomide
- Contraindication to anticoagulant drugs
- Safeguard justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Lenalidomide in Kaposi Disease Associated With HIV Infection (ANRS 154/LENAKAP)
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.
Read the detailed description
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.
The observation period is 48 weeks. The main criteria is evaluated at 24 weeks Inclusion period: 72 weeks from the setting-up meeting.Lenalidomide will be stopped in the case of progression and the patients will be considered as drop-out from the trial, but will be taken into account in the final analysis.
Two-steps procedure: 14 evaluable patients in the first step; if one response to treatment is observed, other patients are included up to 25 evaluable patients.
- Conditions
- HIV Infection Associated Kaposi Disease
- Being tested
- Lenalidomide
- Keywords
- Lenalidomide, Kaposi, HIV, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
oral course, 25 mg, day 1 to 21, per month, 7 days of wash-out each month. Duration according to initial response: 24 weeks and 12 weeks more if complete remission, 24 weeks more if partial remission or stable disease and stop in case of progression.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
For all patients clinical tumour evaluation : complete clinical examination, tumour scoring according to the Aids Clinical Trials Group (ACTG) and The Physician's Global Assessment (PGA) and laboratory assessment.
Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants. Such patients will be treated under the physician's responsability.
Measured: Clinical benefit at week 24
Secondary outcomes (7)
To estimate the safety of lenalidomide
All patients that have started one dose of active treatment will be included in the analysis of safety.
Adverse event will be described precisely for each patient and for each event according to ANRS adverse events criteria. A descriptive analysis of each laboratory result and vital signs will be provided.
Measured: From Week 0 to Week 48
To estimate the time to the response and the duration of the response
Measured: From Week 0 to Week 48
To evaluate the efficacy of treatment at 48 weeks
The analysis of efficacy will determine the proportion of patients with objective response according to the Physical Global Assessment (PGA) score at week 24 and using ACTG criteria for Kaposi.
Measured: Week 48
To evaluate the efficacy using ACTG criteria
Measured: From Week 0 to Week 48
To evaluate the survival and the survival with no progression
Measured: From Week 0 to Week 48
To describe the evolution of virologic and immunological parameters
To describe the evolution of virologic and immunological parameters:
CD4 and CD8 cell counts, Plasma HIV and HHV8 loads
Measured: From Week 0 to Week 48
To estimate the safety of lenalidomide
All patients that have started one dose of active treatment will be included in the analysis of safety.
Adverse event will be described precisely for each patient and for each event according to French AIDS Agency (ANRS) adverse events criteria. A descriptive analysis of each laboratory result and vital signs will be provided.
Measured: From Week 0 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Infection Associated Kaposi DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Valerie Martinez, MD, PhD, Principal investigator, APHP, Hopital Beclere, Clamart FranceDominique Costagliola, PhD, Study director, U943 INSERM and Université Pierre et Marie Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282047
- Sponsor's protocol ID
- ANRS 154 LENAKAP
- Other IDs
- 2010-022898-33
- Acronym
- LENAKAP
- Status last verified
- Jul 2014
- First submitted
- 21 Jan 2011
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pourcher V, Desnoyer A, Assoumou L, Lebbe C, Curjol A, Marcelin AG, Cardon F, Gibowski S, Salmon D, Chennebault JM, Poizot-Martin I, Peytavin G, Boue F, Costagliola D. Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. AIDS Res Hum Retroviruses. 2017 Jan;33(1):1-10. doi: 10.1089/AID.2016.0069. Epub 2016 Sep 7.
PubMed 27405442
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Lenalidomide in Kaposi Disease Associated With HIV Infection (ANRS 154/LENAKAP)
- ClinicalTrials.gov ID
- NCT01282047
- Acronym / sponsor ID
- LENAKAP / ANRS 154 LENAKAP
- Conditions
- HIV Infection Associated Kaposi Disease
- Keywords
- Lenalidomide, Kaposi, HIV, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Celgene
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The observation period is 48 weeks. The main criteria is evaluated at 24 weeks Inclusion period: 72 weeks from the setting-up meeting.Lenalidomide will be stopped in the case of progression and the patients will be considered as drop-out from the trial, but will be taken into account in the final analysis.
Two-steps procedure: 14 evaluable patients in the first step; if one response to treatment is observed, other patients are included up to 25 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomideoral course, 25 mg, day 1 to 21, per month, 7 days of wash-out each month. Duration according to initial response: 24 weeks and 12 weeks more if complete remission, 24 weeks more if partial remission or stable disease and stop in case of progression. | Drug | Lenalidomide |
Primary outcome
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART).
Time frame: Clinical benefit at week 24
For all patients clinical tumour evaluation : complete clinical examination, tumour scoring according to the Aids Clinical Trials Group (ACTG) and The Physician's Global Assessment (PGA) and laboratory assessment. Any patient in documented progression during treatment will be withdrawn from the trial and declared to be in disease progression for the final evaluation but followed monthly like other participants. Such patients will be treated under the physician's responsability.
7 secondary outcomes
To estimate the safety of lenalidomide
Time frame: From Week 0 to Week 48
To estimate the time to the response and the duration of the response
Time frame: From Week 0 to Week 48
To evaluate the efficacy of treatment at 48 weeks
Time frame: Week 48
To evaluate the efficacy using ACTG criteria
Time frame: From Week 0 to Week 48
To evaluate the survival and the survival with no progression
Time frame: From Week 0 to Week 48
To describe the evolution of virologic and immunological parameters
Time frame: From Week 0 to Week 48
To estimate the safety of lenalidomide
Time frame: From Week 0 to Week 48
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 27405442Pourcher V, Desnoyer A, Assoumou L, Lebbe C, Curjol A, Marcelin AG, Cardon F, Gibowski S, Salmon D, Chennebault JM, Poizot-Martin I, Peytavin G, Boue F, Costagliola D. Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. AIDS Res Hum Retroviruses. 2017 Jan;33(1):1-10. doi: 10.1089/AID.2016.0069. Epub 2016 Sep 7.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Martinez, MD, PhD principal investigator
APHP, Hopital Beclere, Clamart France
Dominique Costagliola, PhD study director
U943 INSERM and Université Pierre et Marie Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide in people with HIV Infection Associated Kaposi Disease, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of treatment with Lenalidomide in progressive Kaposi disease in Human immunodeficiency virus (HIV)-infected patients receiving Combined Antiretroviral Therapy (cART). (time frame: Clinical benefit at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.