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Anti-Infective Agents

Pomalidomide

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

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.

Laboratory Biomarker Analysis

Susan E. Krown, MD

Samantha Vogt, MD, MPH

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.

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals With Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)

General estimating equations will be used to evaluate changes in cytokine levels over time. Logistic regression analyses will be used to evaluate the association between cytokine levels and clinical response.

The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.

The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate

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.

Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated using generalized estimating equations.

Changes in CD4 counts and HIV viral load will be evaluated using generalized estimating equations.

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

AIDS Malignancy Consortium

Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with complete response, partial response, or stable disease may continue pomalidomide for an additional 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray imaging throughout the trial. Patients may CT as clinically indicated. Patients also undergo blood sample collection and may optionally undergo tissue biopsy during screening and on the trial.

Biopsy

Biospecimen Collection

Computed Tomography

X-Ray Imaging

Site Public Contact

Erin G. Reid

Marco Ruiz

Paul G. Rubinstein

Richard F. Ambinder

Eric Marks

Lee Ratner

Haiying Cheng

Philip A. Friedlander

Barbara T. Ma

Robert A. Baiocchi

Patricia A. Locantore-Ford

Elizabeth Y. Chiao

David M. Aboulafia

Samantha L Vogt

This phase II trial studies the effect of pomalidomide in treating patients with Kaposi sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells.

PRIMARY OBJECTIVE:

I. To assess the proportion of participants with Kaposi sarcoma (KS) (with or without human immunodeficiency virus \[HIV\], regardless of previous treatment status) treated with pomalidomide who respond to treatment with a durable response (i.e., response duration of at least one year).

SECONDARY OBJECTIVES:

I. To measure the overall response rate (ORR), defined as achieving a complete response (CR) or partial response (PR) post-treatment initiation, and report 95% confidence intervals (CI) in the overall study population.

Ia. To measure the ORR in the HIV positive study population. Ib. To measure the ORR in the HIV unrelated study population. II. To estimate the ORR in subgroups of KS in regard to HIV and previous treatment status.

III. To assess the safety of pomalidomide therapy. IV. To describe changes in visceral disease among those presenting with evaluable visceral disease.

V. To assess response duration in participants treated with pomalidomide.

EXPLORATORY OBJECTIVES:

I. To assess the effect of pomalidomide treatment on the tumor microenvironment and explore the relationship with clinical response.

II. To describe the effects of pomalidomide on CD4 lymphocyte counts and HIV viral load in HIV positive (+) participants.

III. To assess the effect of pomalidomide treatment on serum biomarkers and explore the relationship with clinical response.

IV. To assess Kaposi's sarcoma-associated herpesvirus (KSHV) viral copy number in plasma and explore whether changes correlate with clinical outcome.

V. To assess the effects of pomalidomide on viral and cellular transcription in KS tumor biopsies and explore the relationship with clinical response.

VI. To biobank clinical samples for future potential studies on the immune phenotype and viral and cellular transcription and to explore the relationship 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 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with complete response, partial response, or stable disease may continue pomalidomide for an additional 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray imaging throughout the trial. Patients may undergo computed tomography (CT) as clinically indicated. Patients also undergo blood sample collection and may optionally undergo tissue biopsy during screening and on the trial.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Pomalidomide Treatment in Patients With Kaposi Sarcoma

A Multicenter Phase II Study of Pomalidomide Monotherapy in Kaposi Sarcoma

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Will assess the effect of pomalidomide treatment on the tumor microenvironment and explore the relationship with clinical response and summarize over time. Descriptive statistics for changes in tumor micro-environment will be calculated for all participants and according to clinical response to examine pre- and post-treatment differences and to explore the relationship with clinical response. Changes from baseline will be explored with one-sample nonparametric tests.

Will assess KSHV viral copy number in plasma and explore whether changes correlate with clinical outcome and summarize this data over time. Descriptive statistics for changes in KSHV viral copy number will be calculated for all patients and according to clinical response to examine pre- and post-treatment differences and to explore the relationship with clinical response. Changes from baseline will be explored with one-sample nonparametric tests

Will assess the effect of pomalidomide treatment on serum biomarkers and explore the relationship with clinical response and summarize this data over time. Descriptive statistics for changes in serum biomarkers will be calculated for all patients and according to clinical response to examine pre- and post-treatment differences and to explore the relationship with clinical response. Changes from baseline will be explored with one-sample nonparametric tests.

The Kaplan-Meier (K-M) method will be used to describe duration of response for all treated participants. The cumulative proportion of study participants still in response at one year will be estimated using the point estimate and the 95% confidence interval using Greenwood's formula for the standard error of the K-M estimate. The proportional hazards model will be used to evaluate the association of human immunodeficiency virus (HIV) status and pretreatment status on duration of response.

The binomial proportion and its 95% confidence interval will be used to estimate ORR in four groups defined by HIV status and pretreatment status (HIV+, pretreated; HIV+, treatment naive; HIV-, pretreated and HIV-, treatment naive). In addition, the binomial proportion and its 95% confidence interval will be used to describe the ORR for HIV+ and HIV- participants, and those that were pretreated and treatment naïve.

Will be assessed using version Common Terminology Criteria for Adverse Events 5.0. Adverse events observed on this study will be summarized by organ system, severity grade and relationship to pomalidomide. Frequency and severity of adverse events will be tabulated at the event and person level.

For those with evaluable visceral disease, changes in visceral disease will be descriptively reported.

For deaths unrelated to progressive disease, duration of response will be censored at the date of the last Kaposi sarcoma (KS) evaluation during which the participant was determined to still be in response.

Altretamine

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1 and 15. Patients with disease progression after 2 or more courses who have not experienced toxicity may receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of further disease progression or unacceptable toxicity.

Pharmacological Study

Quality-of-Life Assessment

Recombinant EphB4-HSA Fusion Protein

Ida C. Wong-Sefidan

Adrienne Suazo

William Wachsman, MD, PhD

Terry Ann Lynch

Juan C Ramos, MD

Quin Boynes

Joan Cain, MD

Paul Rubinstein, MD

Laura Clark, PA-C

Richard Ambinder, MD

Lee Ratner, M.D.

Austin Anderson

David Aboulafia, MD

Ida Wong-Sefidan

This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of blood vessels that provide blood to the cancer, and may also prevent cancer cells from growing.

PRIMARY OBJECTIVES:

I. To evaluate the clinical response and toxicity of recombinant EphB4-HSA fusion protein (sEphB4-HSA) (at initial dosing of 15 mg/kg every 2 weeks) in participants with Kaposi sarcoma.

SECONDARY OBJECTIVES:

I. To assess the safety of sEphB4-HSA in participants with Kaposi sarcoma (KS). II. To determine trough level exposure of sEphB4-HSA and correlate with tumor response.

III. To characterize the pharmacodynamics of sEphB4-HSA and correlate these effects with clinical response.

IV. Effects on viral replication and gene expression of human herpes virus-8 (HHV-8).

V. Changes in vascular endothelial growth factor (VEGF)-Notch-EphrinB2 angiogenic pathway.

VI. Effects on immune response and modulation. VII. Effects on tumor cell apoptosis and proliferation. VIII. Effects on sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV.

IX. To archive peripheral blood mononuclear cells (PBMCs) and tissue samples to be used in conjunction with samples collected in subsequent trials of sEphB4-HSA for future studies including identification of biomarkers predictive of response.

X. To evaluate the clinical response and toxicity of sEphB4-HSA (at increased dosing of 10 mg/kg every week) in participants with KS.

TERTIARY OBJECTIVES:

I. Describe baseline quality of life (QOL) scores, using the functional assessment of HIV Infection (FAHI) + Kaposi sarcoma (KS) questionnaire, in participants with KS, and explore changes in QOL of participants on treatment with sEphB4-HSA.

OUTLINE:

Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 1 hour on days 1 and 15. Patients with disease progression after 2 or more courses who have not experienced toxicity may receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of further disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 month; patients with partial response or better are followed up every 3 months for up to 1 year.

sEphB4-HSA in Treating Patients With Kaposi Sarcoma

A Phase II Study of sEphB4-HSA in Kaposi Sarcoma

Five measures of overall quality of life will be scored: physical well-being, emotional well-being, functional and global well-being, social well-being, and cognitive functioning. For KS-specific symptoms, responses may be dichotomized to reflect positive or negative impact of these symptoms. General estimating equations using a log-binomial model will be used to assess changes in these symptoms over time.

The observed proportions of participants experiencing clinical response and unacceptable toxicity will be calculated with 95% confidence intervals. For clinical response, the Kaplan-Meier method will be used to estimate the distribution for time to death assessed for up to 1 month after treatment completion; for time to progression assessed from chemotherapy initiation to first documented progression up to 1 month after treatment completion; and for time to response assessed from the first dose until first documented response up to 1 month after completion of treatment. The Kaplan-Meier method will then be used to estimate the distribution of time to response, time to relapse, and time to death. Time to response is the time from the first dose until documented first response. Time to progression is the time from first dose to first documented progression. Response duration is the time from first documented response to first documented progression.

Adverse events will be tabulated according to type and severity.

Descriptive statistics and graphical displays will be used to evaluate correlation between response and pharmacodynamics of EphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.

Descriptive statistics and graphical displays will be used to evaluate correlation between response and trough levels of EphB4-HSA. Depending on the number enrolled, the association between clinical response and changes in trough levels, pharmacodynamic endpoints, viral copy number, protein expression and activation status, and finally immune cell counts and activation status will be investigated using the nonparametric Wilcoxon rank sum test.

Vasgene Therapeutics, Inc

Recurrence

Nelfinavir

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

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.

Nelfinavir Mesylate

Soren Gantt

This pilot phase II trial studies how well nelfinavir mesylate works in treating patients with kaposi sarcoma. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the efficacy of a therapeutic escalation strategy consisting of standard dose nelfinavir (nelfinavir mesylate), followed by high dose nelfinavir, for the treatment of Kaposi sarcoma (KS) tumor lesions. With 36 evaluable participants, the null hypothesis will be rejected if 11 or more participants respond.

SECONDARY OBJECTIVES:

I. To evaluate the safety of high dose nelfinavir among participants with KS. II. To assess the effect of nelfinavir on Kaposi sarcoma-associated herpesvirus (KSHV) lytic gene expression in tumor tissue.

III. To correlate nelfinavir and the primary active metabolite, M8, concentrations with tumor response, antiviral response, and adverse effects in participants with KS.

IV. To assess the effect of nelfinavir on KSHV copy number in saliva.

TERTIARY OBJECTIVES:

I. To assess the effect of nelfinavir on KSHV copy number in PBMC and plasma. II. To assess the effect of nelfinavir on herpes simplex virus (HSV), cytomegalovirus (CMV) and Epstein-Barr virus (EBV) copy number in saliva.

OUTLINE:

STANDARD DOSE NELFINAVIR MESYLATE: Patients receive standard dose nelfinavir mesylate orally (PO) twice daily (BID) for 4 weeks in the absence of progressive disease (PD). Patients with PD at 4 weeks proceed to high-dose nelfinavir mesylate. At week 8, if there is stable disease (SD) or partial response (PR), patients advance to high-dose nelfinavir mesylate. Patients discontinue standard dose nelfinavir mesylate 4 weeks after documentation of complete response (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 mesylate 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.

After completion of study treatment, patients are followed up at 8 weeks.

Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma

A Pilot Study of Nelfinavir for the Treatment of Kaposi Sarcoma

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.

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.

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

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

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.

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).

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.

AIDS and Cancer Specimen Resource

Among 36 participants, 31 participants received the high dose of nelfinavir after receiving the standard dose of nelfinavir.

Mortality report was based on all 36 participants. For mortality report in high dose was based on 31 participants which is a subset of 36 participants.

Adverse Event and Serious Adverse Event reports were based on 36 participants treated with standard dose levels of nelfinavir and 31 participants treated with high dose after standard dose.

This study is not parallel arm study. Nelfinavir dose will be administrated in the sequential manner according to the response.

AE summary is based on participants who received high dose. There were totally 31 participants received high dose after receiving standard dose.

All patients will received standard dose of nelfinavir (1250 mg BID) for at least 4 weeks. If after 4 weeks there is progressive disease (PD), the participant will advance to the high dose nelfinavir (3125 mg BID). If by 8 weeks there is stable disease (SD) or partial response (PR) at the standard dose, the participant will advance to high dose of nelfinavir.

The high dose nelfinavir treatment will be continued for at least 4 weeks. If there is progressive disease (PD) documented after 4 weeks at the high dose level, nelfinavir will be discontinued. If there is stable disease (SD) or partial response (PR) at the high dose level, high dose nelfinavir will be continued for up to 16 weeks. If there is a complete response (CR), high dose treatment will be discontinued 4 weeks after documentation of complete response.

High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate)

This study is not parallel arm study. Nelfinavir dose will be administrated in the sequential manner according to the response.

AE summary is based on participants who received standard dose. There were totally 36 participants received standard dose initally.

All patients will received standard dose of nelfinavir (1250 mg BID) for at least 4 weeks. If there is complete response (CR) at any time at the standard dose, nelfinavir will be discontinued 4 weeks after documentation of CR.

Standard Dose Treatment (Nelfinavir Mesylate)

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.

Laboratory Biomarker Analysis: Correlative studies

Nelfinavir Mesylate: Given PO

Treatment (Nelfinavir Mesylate)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Non-Hispanic White

Non-Hispanic Black

Hispanic

Unknown

Race/Ethnicity, Customized

HIV status

Deukwoo Kwon

Among 30 HIV-positive patients, there are 25 HIV-positive who were treated with high dose.

Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Positive Participants

There are 6 HIV-negative who were treated with high dose.

Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Negative Participants

Frequency and Severity of Adverse Events in HIV-positive Participants as Assessed by CTCAE v4.0

Frequency and Severity of Adverse Events in HIV-negative Participants as Assessed by CTCAE v4.0

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection	NCT03601806	Human Immunodef... Skin Kaposi Sar...	Laboratory Biom... Pomalidomide	18 Years -	AIDS Malignancy Consortium
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection	NCT03601806	Human Immunodef... Skin Kaposi Sar...	Laboratory Biom... Pomalidomide	18 Years -	AIDS Malignancy Consortium
Pomalidomide Treatment in Patients With Kaposi Sarcoma	NCT04577755	Skin Kaposi Sar...	Biopsy Biospecimen Col... Computed Tomogr... Pomalidomide X-Ray Imaging	18 Years -	National Cancer Institute (NCI)
Pomalidomide Treatment in Patients With Kaposi Sarcoma	NCT04577755	Skin Kaposi Sar...	Biopsy Biospecimen Col... Computed Tomogr... Pomalidomide X-Ray Imaging	18 Years -	National Cancer Institute (NCI)
sEphB4-HSA in Treating Patients With Kaposi Sarcoma	NCT02799485	Skin Kaposi Sar...	Laboratory Biom... Pharmacological... Quality-of-Life... Recombinant Eph...	18 Years -	AIDS Malignancy Consortium
Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma	NCT03077451	Recurrent Kapos... Skin Kaposi Sar...	Laboratory Biom... Nelfinavir Mesy...	18 Years -	AIDS Malignancy Consortium

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