Trial · NCT03077451
Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma
NCT03077451, Phase 2, Completed, AIDS Malignancy Consortium; results first posted 2024-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma. Trials, record NCT03077451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03077451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma
- NCT number
- NCT03077451
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- AIDS Malignancy Consortium
- Conditions
- Recurrent Kaposi Sarcoma, Skin Kaposi Sarcoma
- Interventions
- Laboratory Biomarker Analysis, Nelfinavir Mesylate
- First posted
- 2017-03-13
- Last updated
- 2025-12-17
- Results first posted
- 2024-02-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Positive Participants | Baseline up to 16 weeks | The binomial proportion and its exact 95% confidence interval will be used to estimate the overall response rate in the study. Overall response is defined as Complete response or partial response. Response and progression will be evaluated in this study using the AIDS Clinical Trials Groups (ACTG) response criteria for Kaposi sarcoma. Complete response (CR) is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Partial response (PR) is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks; OR Complete flattening of at least 50% of all previously raised lesions; OR 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions. |
| Primary | Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Negative Participants | Baseline up to 16 weeks | The binomial proportion and its exact 95% confidence interval will be used to estimate the response rate in the study. Response rate will be estimated using the binomial proportion and it's exact 95% confidence interval for HIV negative participants. |
| Secondary | Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | Baseline to up to 16 weeks | Frequency of adverse events and their severity will be tabulated to evaluate tolerance of high dose nelfinavir in the treatment of KS in participant who are HIV-positive |
| Secondary | Frequency and Severity of Adverse Events in HIV-negative Participants as Assessed by CTCAE v4.0 | Baseline to up to 16 weeks | Frequency of adverse events and their severity will be tabulated to evaluate tolerance of high dose nelfinavir in the treatment of KS in participant who are HIV-negative |
| Secondary | Assess the Effect of Nelfinavir on KSHV Gene Expression in Tumor Tissue | Baseline to up to 16 weeks | Descriptive statistics will be used for changes in the relative abundance of all latent and lytic viral mRNA relative to cellular mRNA by expression array, and changes in the percentage of cells staining for K8.1 (lytic) and LANA (latent) antigens by immunohistochemistry. Generalized estimating equations will be used to evaluate these changes over time. Normalizing transformations will be used as needed. |
| Secondary | Correlate Nelfinavir and the Primary Active Metabolite, M8, Concentrations With Tumor Response, Antiviral Response, and Adverse Effects in Participants With KS. | Baseline to up to 16 weeks | Trough nelfinavir/M8 concentrations will be summarized using descriptive statistics and 95% confidence intervals. This outcome will also be displayed graphically as a trend in drug levels over time. The relationship between dose and drug exposure of nelfinavir/M8 and the pharmacodynamic (PD) effects will be determined using Pearson's correlation coefficient (r2) or appropriate non-parametric statistics for dichotomous and categorical variables (e.g., Mann-Whitney U-test or Kruskal-Wallis analysis of variance by ranks). |
| Secondary | Assess the Effect of Nelfinavir on KSHV Copy Number in Saliva | Up to 16 weeks | Pre-treatment oral samples and oral samples during treatment will be collected from each participant. The sampling frequency is irrelevant as long as the quantity is sufficient. With 36 participants, a decrease in the proportion of participants with detectable KSHV DNA from 50% at baseline to 1% on treatment can be detected at the one-sided 0.05 significance level with 0.99 power using McNemar's test. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Positive Participants | Baseline up to 16 weeks | Among 30 HIV-positive patients, there are 25 HIV-positive who were treated with high dose. | percentage of overall response patients | NUMBER |
| PRIMARY | Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Negative Participants | Baseline up to 16 weeks | There are 6 HIV-negative who were treated with high dose. | percentage of overall response patients | NUMBER |
| SECONDARY | Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | Baseline to up to 16 weeks | High dose of nelfinavir after standard dose of nelfinavir in the treatment of KS in participant who are HIV-positive. Overall Number of Participants Analyzed signifies all participants received high does of nelfinavir assessed for adverse events. Number Analyzed represents the number of participants affected with the total number of observed adverse events reported. | Number of adverse events | NUMBER |
| SECONDARY | Frequency and Severity of Adverse Events in HIV-negative Participants as Assessed by CTCAE v4.0 | Baseline to up to 16 weeks | High dose of Nelfinavir after standard dose among HIV-negative participants. Overall Number of Participants Analyzed signifies all participants received high does of nelfinavir assessed for adverse events. Number Analyzed represents the number of participants affected with the total number of observed adverse events reported. | Number of adverse events | NUMBER |
| SECONDARY | Assess the Effect of Nelfinavir on KSHV Gene Expression in Tumor Tissue | Baseline to up to 16 weeks | LANA and K8.1 were reported using percentage of cells with median and IQR. | percentage of cells | MEDIAN |
| SECONDARY | Correlate Nelfinavir and the Primary Active Metabolite, M8, Concentrations With Tumor Response, Antiviral Response, and Adverse Effects in Participants With KS. | Baseline to up to 16 weeks | Participants who received study treatment. Area under the curve (AUC) of M8 measurements was reported by tumor response and adverse event grade using median and inter-quartile range (IQR). | ng*cycle/mL | MEDIAN |
| SECONDARY | Assess the Effect of Nelfinavir on KSHV Copy Number in Saliva | Up to 16 weeks | Participants who received study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Positive Participants | Treatment (Nelfinavir Mesylate) | 32 | 95% Confidence Interval 14.9 to 53.5 | percentage of overall response patients | |
| Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Negative Participants | Treatment (Nelfinavir Mesylate) | 16.7 | 95% Confidence Interval 0.4 to 64.1 | percentage of overall response patients | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Anemia | 7 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Blood and Lymphatic System Disorder | 2 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Abdominal Pain | 3 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Constipation | 2 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Diarrhea | 42 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Nausea | 7 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Vomiting | 2 | Number of adverse events | |
| Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0 | High Dose of Nelfinavir in the Treatment of KS in Participant Who Are HIV-positive | Edema Limbs | 6 | Number of adverse events |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Nelfinavir Mesylate) | 36 | |
| Overall Study | COMPLETED | Treatment (Nelfinavir Mesylate) | 20 | |
| Overall Study | NOT COMPLETED | Treatment (Nelfinavir Mesylate) | 16 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 6 | 31 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Standard Dose Treatment (Nelfinavir Mesylate) | 0 | 36 | 0 |
| other | DIARRHEA | Gastrointestinal disorders | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 24 | 31 | 51 |
| other | DIARRHEA | Gastrointestinal disorders | Standard Dose Treatment (Nelfinavir Mesylate) | 3 | 36 | 4 |
| other | DIZZINESS | Nervous system disorders | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 4 | 31 | 4 |
| other | DIZZINESS | Nervous system disorders | Standard Dose Treatment (Nelfinavir Mesylate) | 0 | 36 | 0 |
| other | DRY SKIN | Skin and subcutaneous tissue disorders | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 2 | 31 | 2 |
| other | DRY SKIN | Skin and subcutaneous tissue disorders | Standard Dose Treatment (Nelfinavir Mesylate) | 0 | 36 | 0 |
| other | FATIGUE | General disorders | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 2 | 31 | 3 |
| other | FATIGUE | General disorders | Standard Dose Treatment (Nelfinavir Mesylate) | 0 | 36 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 0 | 31 |
| Total, all-cause mortality | Standard Dose Treatment (Nelfinavir Mesylate) | 0 | 36 |
| Total, other adverse events | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 28 | 31 |
| Total, other adverse events | Standard Dose Treatment (Nelfinavir Mesylate) | 5 | 36 |
| Total, serious adverse events | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | 1 | 31 |
| Total, serious adverse events | Standard Dose Treatment (Nelfinavir Mesylate) | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA121947 | Consortium for Advancing Management and Prevention of Cancer in People with HIV | SPARANO, JOSEPH A. | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) vs Standard Dose Treatment (Nelfinavir Mesylate): deaths from any cause | Trial comparisons |
| High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) vs Standard Dose Treatment (Nelfinavir Mesylate): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03077451
GET https://conductscience.org/api/trials/v1/NCT03077451/results?page=2