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Protease Inhibitor

Nelfinavir Mesylate for Kaposi's Sarcoma

Phase 2
Waitlist Available
Led By Soren Gantt
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Study Summary

This trial studies how well nelfinavir mesylate works in treating patients with kaposi sarcoma.

Eligible Conditions
  • Kaposi's Sarcoma
  • Kaposi Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Negative Participants
Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Positive Participants
Secondary outcome measures
Assess the Effect of Nelfinavir on KSHV Copy Number in Saliva
Assess the Effect of Nelfinavir on KSHV Gene Expression in Tumor Tissue
Correlate Nelfinavir and the Primary Active Metabolite, M8, Concentrations With Tumor Response, Antiviral Response, and Adverse Effects in Participants With KS.
+2 more
Other outcome measures
Effect of Nelfinavir on CMV Copy Number in Saliva
Effect of Nelfinavir on EBV Copy Number in Saliva
Effect of Nelfinavir on HSV Copy Number in Saliva
+1 more

Side effects data

From 2023 Phase 2 trial • 36 Patients • NCT03077451
8%
DIARRHEA
6%
NAUSEA
6%
VOMITING
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Treatment (Nelfinavir Mesylate)
High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nelfinavir mesylate)Experimental Treatment2 Interventions
DOSE NELFINAVIR MESYLATE: Patients receive standard dose nelfinavir mesylate PO BID for 4 weeks in the absence of PD. Patients with PD at 4 weeks proceed to high-dose nelfinavir. At week 8, if there is SD or PR, patients advance to high-dose nelfinavir mesylate. Patients discontinue standard dose nelfinavir mesylate 4 weeks after documentation of CR. HIGH DOSE NELFINAVIR MESYLATE: Patients with PD continue to receive high-dose nelfinavir mesylate PO BID for 4 more weeks. If there is PD documented after 4 weeks at the high dose level, nelfinavir is discontinued. If there is SD or PR, patients continue receiving nelfinavir mesylate for 16 weeks. If there is CR, patients discontinue high-dose nelfinavir mesylate 4 weeks after documentation of CR.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelfinavir Mesylate
2013
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterOTHER
442 Previous Clinical Trials
582,490 Total Patients Enrolled
University of ArkansasOTHER
486 Previous Clinical Trials
150,317 Total Patients Enrolled
AIDS and Cancer Specimen ResourceOTHER
7 Previous Clinical Trials
994 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma
2017. "Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03077451.
~4 spots leftby Apr 2025
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