Human Immunodeficiency Virus 1 PositivePhase 2NCT03601806
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
A Phase 2 study testing Laboratory Biomarker Analysis and Pomalidomide in people with Human Immunodeficiency Virus 1 Positive and Skin Kaposi Sarcoma, run by AIDS Malignancy Consortium at 3 sites in 3 countries.
Trial summary
This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus 1 Positive, Skin Kaposi Sarcoma
- What is being tested?
- Laboratory Biomarker Analysis and Pomalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 26 Apr 2021to 10 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have measurable cutaneous KS that has been pathologically confirmed by an acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC)-approved pathologist; diagnostic tissue must be available to satisfy the tissue submission requirements for central pathology review
- Participants may not show evidence for ongoing improvement in KS lesions in the 4 weeks prior to enrollment
- HIV positive. Documentation of HIV-1 infection by means of any one of the following:
- HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody antigen combination assay;
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky performance status [KPS] >= 50)
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- Life expectancy >= 12 weeks
- Hemoglobin >= 8 g/dL
- Absolute neutrophil count (ANC): >= 1,000 cells/mm^3 (1.0 x 10^9/L)
- Platelets: >= 75,000 cells/mm^3 (75.0 x 10^9/L)
- Total bilirubin: =< 1.5 times the upper limit of normal (ULN), unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be =< 2 times the ULN
- Serum aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) / alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN
- Estimated or measured creatinine clearance > 60 mL/minute (1.00 mL/s) (serum creatinine =< 2.0 mg/dL / 176.8 umol/L)
- Currently receiving local standard of care antiretroviral therapy (ART) for >= 12 weeks, with HIV viral load =< 400 copies/mL; participants are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed
- A female of childbearing potential (FCBP) is a female who has achieved menarche at some point and who meets one of the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), or 3) does not have a serum or plasma follicle stimulating hormone (FSH) > 40 mIU/mL and a history of amenorrhea x >= 1 year
- FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, including one of the following highly effective, long-acting methods, DepoProvera, an intrauterine device (IUD), an implant*, or bilateral tubal ligation, if it can be verified that the procedure was performed, and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing
- NOTE: Implants containing levonorgestrel and etonogestrel are prohibited in women receiving efavirenz, as drug interactions will render the implants ineffective
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy
- All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; serum or urine pregnancy testing will be repeated in FCBP, and must be negative, within 24 hours of starting each new cycle of pomalidomide
- Able to take aspirin (>= 81 mg) daily as prophylactic anticoagulation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants who are receiving any other investigational agents
- Any prior use of thalidomide, lenalidomide, or pomalidomide
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide
- Visceral disease requiring cytotoxic chemotherapy (i.e., pulmonary KS, symptomatic gastrointestinal KS). KS-related lymphedema is permitted.
- Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited; in order to be eligible, participants taking zidovudine must change to a different regimen at least 7 days prior to therapy initiation; changes to antiretroviral therapy (ART) therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.)
- Use of medications or substances that are strong inhibitors of CYP1A2, which include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine, and ticlopidine is prohibited
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- Use of erythropoietin is prohibited
- Co-administration of corticosteroids greater than doses required for treatment of adrenal insufficiency is prohibited
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection for which the participant has not completed at least 14 days of therapy prior to study enrollment and/or is not clinically stable; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with pomalidomide
- Specific KS therapy, including cytotoxic chemotherapy but not including ART, within the past 4 weeks
- Use of other anticancer treatments or agents within the past 4 weeks
- History of malignant tumors other than KS, unless:
- In complete remission for >= 1 year, or
- Completely resected basal cell carcinoma, or
- In situ squamous cell carcinoma of the cervix or anus
- Grade >= 1 peripheral neuropathy
- History of myocardial infarction (MI), cerebrovascular accident, or venous or arterial thromboembolism, unless line-related thrombosis without embolus occurring within 1 year prior to study entry
- Known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome
- Any condition, including the presence of current laboratory abnormalities or other factor that, in the opinion of the investigator, places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals With Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)
This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated Kaposi sarcoma (KS) in sub-Saharan Africa and is safe and tolerable.
SECONDARY OBJECTIVES:
- To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population.
TERTIARY OBJECTIVES:
- To assess the effect of pomalidomide treatment on serum cytokine levels. II. To evaluate if changes in serum cytokine levels correlate with clinical response.
OUTLINE:
Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 48 weeks.
- Being tested
- Laboratory Biomarker Analysis, Pomalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
PomalidomideDrug
Also called 4-Amino thalidomide, Actimid, CC-4047, Imnovid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pomalidomide) | Experimental | Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.
Measured: Up to 48 weeks
Complete Response Rate
The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate
Measured: Up to 48 weeks
Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Incidence of Grade 3 or higher toxicity will be reported using percentage and corresponding 95% confidence interval. The binomial proportion and its 95% exact confidence interval will be used to estimate the proportion of participants who experience a grade 3 or higher toxicity.
Measured: Up to 1 year
Secondary outcomes (2)
Changes in CD4 T Cell Count
Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated.
Measured: Baseline to up to 1 year
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Changes in CD4 counts and HIV viral load will be evaluated.
Measured: Baseline to up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start26 Apr 2021
- Primary completion29 Nov 2024
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus 1 PositiveStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, Montefiore Medical Center, University of Stellenbosch, Weill Medical College of Cornell University, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Susan E. Krown, MD, Study chair, AIDS Malignancy ConsortiumSamantha Vogt, MD, MPH, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601806
- Sponsor's protocol ID
- AMC-100
- Other IDs
- NCI-2017-00390, AMC-100, AMC-100, UM1CA121947
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2018
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals With Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)
- ClinicalTrials.gov ID
- NCT03601806
- Acronym / sponsor ID
- AMC-100
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, Montefiore Medical Center, University of Stellenbosch, Weill Medical College of Cornell University, University of California, Los Angeles
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.
Detailed description
PRIMARY OBJECTIVES:
- To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated Kaposi sarcoma (KS) in sub-Saharan Africa and is safe and tolerable.
SECONDARY OBJECTIVES:
- To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population.
TERTIARY OBJECTIVES:
- To assess the effect of pomalidomide treatment on serum cytokine levels. II. To evaluate if changes in serum cytokine levels correlate with clinical response.
OUTLINE:
Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pomalidomide) | Experimental | Other: Laboratory Biomarker Analysis, Drug: PomalidomidePatients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must have measurable cutaneous KS that has been pathologically confirmed by an acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC)-approved pathologist; diagnostic tissue must be available to satisfy the tissue submission requirements for central pathology review
- Participants may not show evidence for ongoing improvement in KS lesions in the 4 weeks prior to enrollment
- HIV positive. Documentation of HIV-1 infection by means of any one of the following:
- HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody antigen combination assay;
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
Key exclusion criteria (20 listed)
- Participants who are receiving any other investigational agents
- Any prior use of thalidomide, lenalidomide, or pomalidomide
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide
- Visceral disease requiring cytotoxic chemotherapy (i.e., pulmonary KS, symptomatic gastrointestinal KS). KS-related lymphedema is permitted.
- Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited; in order to be eligible, participants taking zidovudine must change to a different regimen at least 7 days prior to therapy initiation; changes to antiretroviral therapy (ART) therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.)
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (pomalidomide) |
| PomalidomideAlso: 4-Amino thalidomide, Actimid, CC-4047, ImnovidGiven PO | Drug | Treatment (pomalidomide) |
Primary outcome
Overall Response Rate
Time frame: Up to 48 weeks
The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.
Complete Response Rate
Time frame: Up to 48 weeks
The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate
Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Time frame: Up to 1 year
Incidence of Grade 3 or higher toxicity will be reported using percentage and corresponding 95% confidence interval. The binomial proportion and its 95% exact confidence interval will be used to estimate the proportion of participants who experience a grade 3 or higher toxicity.
2 secondary outcomes
Changes in CD4 T Cell Count
Time frame: Baseline to up to 1 year
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Time frame: Baseline to up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Susan E. Krown, MD study chair
AIDS Malignancy Consortium
Samantha Vogt, MD, MPH study chair
Johns Hopkins University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis and Pomalidomide in people with Human Immunodeficiency Virus 1 Positive and Skin Kaposi Sarcoma, run by AIDS Malignancy Consortium at 3 sites in 3 countries.
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 21 inclusion and 20 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: finished, as of the sponsor's last update on 13 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 3 sites in Kenya, Malawi, Uganda. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (time frame: Up to 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.