Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas

Tracking Information
First Submitted Date ICMJE	September 1, 2010
First Posted Date ICMJE	September 2, 2010
Last Update Posted Date	August 8, 2017
Actual Study Start Date ICMJE	October 6, 2010
Actual Primary Completion Date	October 14, 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 9, 2015)	Complete response rate assessed by Response Evaluation Criteria in Solid Tumors (Phase II) [ Time Frame: Up to 5 years ]The difference between the complete response rate proportions (i.e., chemo alone vs. chemo + vorinostat) will be tested using the normal approximation for a two sample test of proportions.; Incidence of adverse events (AEs) for each treatment arm assessed by CTCAE v4.0 (Phase II) [ Time Frame: Up to 5 years ]The frequency of AEs and their severity will be tabulated for each treatment arm (i.e., chemo alone and chemo + vorinostat).; Recommended phase II dose of vorinostat determined according to dose-limiting toxicities graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) (Phase I) [ Time Frame: 21 days ]Toxicity data will be presented by severity for each dose group. The incidence of toxicity related dose reductions and treatment discontinuations will be summarized for each dose group. If there are a sufficient number of patients in each dose group, chi square analyses will be used to compare dose groups with respect to the incidence of specific toxicities.
Original Primary Outcome Measures ICMJE; (submitted: September 1, 2010)	Maximum-tolerated dose and recommended phase II dose of vorinostat and risk-adapted chemotherapy with rituximab (Phase I); Toxicity (Phase II); Complete response (Phase II)
Change History	Complete list of historical versions of study NCT01193842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 7, 2017)	Change in CD8 cell counts (Phase I) [ Time Frame: Baseline up to 12 months ]Evaluated using analyses of variance.; Changes in CD4 cell counts (Phase I) [ Time Frame: Baseline up to 12 months ]Evaluated using analyses of variance. For each dose group and for all groups combined, the Wilcoxon signed rank test will be used to evaluate the changes in HIV viral load and CD4 count. If there is sufficient number of patients in each dose group, the Kruskal-Wallis test will be used to compare dose groups with respect to changes in HIV viral load and CD4 count.; Changes in Epstein-Barr virus (EBV) viral load [ Time Frame: Baseline up to 12 months ]Descriptive statistics such as frequencies and percentages will be used to aid in the evaluation of EBV and human herpes virus (HHV)-8 gene expression patterns.; Changes in human herpes virus (HHV)-8 viral load [ Time Frame: Baseline up to 12 months ]Descriptive statistics such as frequencies and percentages will be used to aid in the evaluation of EBV and HHV-8 gene expression patterns.; Changes in human immunodeficiency virus (HIV) viral load [ Time Frame: Baseline up to 12 months ]A repeated measures analysis of variance will be used to assess the effect across time points.; Event-free survival (EFS) (Phase II) [ Time Frame: 1 year ]Binomial proportions and their 95% confidence intervals will be used to determine the 1-year EFS rate.; Overall survival (OS) (Phase II) [ Time Frame: 1 year ]Binomial proportions and their 95% confidence intervals will be used to determine the 1-year OS rates.; Percentage of plasma associated human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) (Phase I) [ Time Frame: Baseline up to 12 months ]Evaluated using analyses of variance. For each dose group and for all groups combined, the Wilcoxon signed rank test will be used to evaluate the changes in HIV viral load and CD4 count. If there is sufficient number of patients in each dose group, the Kruskal-Wallis test will be used to compare dose groups with respect to changes in HIV viral load and CD4 count.; Pharmacokinetic profile and the parameters of clearance and the AUC (area under the curve) (Phase I) [ Time Frame: Up to 12 months ]Summary statistics will be used to describe pharmacokinetic results by dose level. Comparisons across dose levels will be made to assess proportionality or variability of the different parameters.; Tumor response rate (Phase I) [ Time Frame: Up to 5 years ]The tumor response rate will be estimated for each dose group and for all groups combined. The 95% confidence intervals will be constructed for tumor response rates.
Original Secondary Outcome Measures ICMJE; (submitted: September 1, 2010)	1-year event-free survival; 1-year overall survival; Effect of treatment on HIV, HBV, and HHV-8 viral load; Effect of treatment on T-cell subsets (CD4 and CD8) and plasma immunoglobulin levels; Gene expression profiling; EBV gene expression
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas
Official Title ICMJE	A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma
Brief Summary	This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy alone in treating patients with human immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving vorinostat together with combination chemotherapy and rituximab may kill more cancer cells.
Detailed Description	PRIMARY OBJECTIVES: I. Determine the recommended phase II dose (RPTD) of vorinostat that may be used in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride and rituximab (R-DA-EPOCH) (in high-risk disease) in participants with human immunodeficiency virus (HIV)-associated aggressive cluster of differentiation (CD)20 positive non-Hodgkin lymphoma (NHL). (Phase I) II. Determine the overall toxicity rates of R-DA-EPOCH (in high-risk disease) with and without vorinostat. (Phase II) III. Determine the efficacy of the combinations of R-DA-EPOCH (in high-risk disease) with and without vorinostat in HIV-associated aggressive CD20 positive NHL using complete response (CR) rates as study endpoints. (Phase II) SECONDARY OBJECTIVES: I. Determine 1-year event-free survival (EFS) and 1 year overall survival (OS). II. Assess the effect of vorinostat and chemotherapy on latent HIV in memory T cells. III. Assess the effect of vorinostat and/or chemotherapy on HIV, Epstein-Barr virus (EBV), and human herpes virus 8 (HHV-8) viral loads on banked specimens. IV. Assess the effect of vorinostat and/or chemotherapy on T-cell subsets (CD4 and CD8) and plasma immunoglobulin levels. V. Assess the effect of concurrent vorinostat and rituximab on plasma steady-state concentrations of etoposide, doxorubicin (doxorubicin hydrochloride), and vincristine (vincristine sulfate) (on Phase I only). VI. Perform wide human gene expression profiling and methylation studies in tumors banked at baseline. VII. Evaluate EBV and HHV-8 gene expression patterns in positive tumors banked at baseline. OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II study. PHASE I: Patients receive vorinostat orally (PO) once daily (QD) on days 1-5; rituximab intravenously (IV) on day 1; etoposide IV over 24 hours, doxorubicin hydrochloride IV over 24 hours, and vincristine sulfate IV over 24 hours on days 1-4; prednisone PO daily on days 1-5; and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM A (VR-DA-EPOCH): Patients receive vorinostat, rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Phase I. ARM B (DA-R-EPOCH): Patients receive rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Arm A. In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	AIDS-Related Plasmablastic Lymphoma; AIDS-Related Primary Effusion Lymphoma; CD20 Positive; HIV Infection; Plasmablastic Lymphoma; Primary Effusion Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Stage I Diffuse Large B-Cell Lymphoma; Stage I Grade 3 Follicular Lymphoma; Stage II Diffuse Large B-Cell Lymphoma; Stage II Grade 3 Contiguous Follicular Lymphoma; Stage II Grade 3 Non-Contiguous Follicular Lymphoma; Stage III Diffuse Large B-Cell Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage IV Diffuse Large B-Cell Lymphoma; Stage IV Grade 3 Follicular Lymphoma
Intervention ICMJE	Drug: Cyclophosphamide Given IV Other Names: (-)-Cyclophosphamide 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene CP monohydrate CTX CYCLO-cell Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Cyclostine Cytophosphan Cytophosphane Cytoxan Fosfaseron Genoxal Genuxal Ledoxina Mitoxan Neosar Revimmune Syklofosfamid WR- 138719; Drug: Doxorubicin Hydrochloride Given IV Other Names: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI) ADM Adriacin Adriamycin Adriamycin hydrochloride Adriamycin PFS Adriamycin RDF ADRIAMYCIN, HYDROCHLORIDE Adriamycine Adriblastina Adriblastine Adrimedac Chloridrato de Doxorrubicina DOX DOXO-CELL Doxolem Doxorubicin.HCl Doxorubin Farmiblastina FI 106 FI-106 hydroxydaunorubicin Rubex; Drug: Etoposide Given IV Other Names: Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG Lastet Toposar Vepesid VP 16-213 VP-16 VP-16-213; Other: Laboratory Biomarker Analysis Correlative studies; Other: Pharmacological Study Correlative studies; Drug: Prednisone Given PO Other Names: .delta.1-Cortisone 1, 2-Dehydrocortisone Adasone Cortancyl Dacortin DeCortin Decortisyl Decorton Delta 1-Cortisone Delta-Dome Deltacortene Deltacortisone Deltadehydrocortisone Deltasone Deltison Deltra Econosone Lisacort Meprosona-F Metacortandracin Meticorten Ofisolona Orasone Panafcort Panasol-S Paracort PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Predniment Prednisonum Prednitone Promifen Servisone SK-Prednisone; Biological: Rituximab Given IV Other Names: ABP 798 BI 695500 C2B8 Monoclonal Antibody Chimeric Anti-CD20 Antibody CT-P10 IDEC-102 IDEC-C2B8 IDEC-C2B8 Monoclonal Antibody MabThera Monoclonal Antibody IDEC-C2B8 PF-05280586 Rituxan Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar IBI301 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 RTXM83; Drug: Vincristine Sulfate Given IV Other Names: Kyocristine Leurocristine Sulfate Leurocristine, sulfate Oncovin Vincasar Vincosid Vincrex Vincristine, sulfate; Drug: Vorinostat Given PO Other Names: L-001079038 MSK-390 SAHA Suberanilohydroxamic Acid Suberoylanilide Hydroxamic Acid Zolinza
Study Arms	Experimental: Arm A (VR-DA-EPOCH) Patients receive vorinostat PO QD on days 1-5; rituximab IV on day 1; etoposide IV over 24 hours, doxorubicin hydrochloride IV over 24 hours, and vincristine sulfate IV over 24 hours on days 1-4; prednisone PO daily on days 1-5; and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Interventions: Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Etoposide Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Prednisone Biological: Rituximab Drug: Vincristine Sulfate Drug: Vorinostat; Experimental: ARM B (DA-R-EPOCH) Patients receive rituximab, etoposide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and cyclophosphamide as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Interventions: Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Etoposide Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Prednisone Biological: Rituximab Drug: Vincristine Sulfate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: August 7, 2017)	112
Original Estimated Enrollment ICMJE; (submitted: September 1, 2010)	130
Study Completion Date	Not Provided
Actual Primary Completion Date	October 14, 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Participants with histologically or cytologically documented diffuse large B-cell lymphoma (DLBCL) must meet at least 1 of the following risk criteria: Age-adjusted International Prognostic Index (IPI) score: 2-3 Ki-67 >= 80% Histologically, or cytologically documented activated B-cell-like (ABC, also known as post-GCB) subtype Double hit variant, defined as having v-myc avian myelocytomatosis viral oncogene homolog (MYC) gene rearrangement in the presence of B-cell chronic lymphocytic leukemia (CLL)/lymphoma (BCL) 2 or BCL6 gene rearrangement Other aggressive non-DLBCL non-Burkitt non-Hodgkin B-cell lymphoma variants as defined by the 2008 World Health Organization (WHO) classification, including rare CD20 negative B-cell lymphomas (i.e. plasmablastic lymphoma, and primary effusion lymphoma) are also eligible; grade 3B follicular lymphoma is also eligible as long as one the above risk criteria is met; Participants who are untreated or who received a maximum of one (1) cycle of combination chemotherapy, including rituximab-containing regimens, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior to beginning treatment under this protocol, and such cycle will count towards the total maximum of 6 cycles under this study; Documentation of HIV infection at any time prior to study entry; documentation may be molecular (detectable viral ribonucleic acid [RNA] by polymerase chain reaction [PCR]), serologic (positive enzyme-linked immunosorbent assay [ELISA] and positive Western blot), or other federally approved licensed HIV test; prior documentation of HIV seropositivity is acceptable; All stages of disease; Measurable or non-measurable tumor parameter(s); non-measurable tumor parameters are defined as not having bidimensional measurements (e.g., gastric or marrow involvement), but can be followed for response by other diagnostic tests such as gallium, positron emission tomography (PET) imaging, and/or bone marrow biopsy; Performance status (PS) 0, 1, or 2 per the Eastern Cooperative Oncology Group (ECOG) performance status scale (Karnofsky performance score >= 50%); Able to provide informed consent; Total bilirubin =< 1.5 institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); for direct bilirubin > 1.2 due to hepatic involvement by tumor for the initial dose of EPOCH drug adjustment; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN (unless elevated due to secondary lymphomatous involvement of the liver); Negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy; all participants will be required to be screened for hepatitis B and C; per Infectious Disease Society of America (IDSA) and American Association for the Study of Liver Diseases (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen positive [HBsAg+], hepatitis B core antibody positive [HBcore+], hepatitis surface antibody negative [HBsAB-]) will be required to be on anti-hepatitis B therapy, during the study, in order to be eligible; participants will be permitted to enroll in the study provided liver function tests meet criteria, and there is no evidence of cirrhosis; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; however all participants who present with acute hepatitis B or show normal transaminases and are HBsAg+ and immunoglobulin (Ig)M+ for hepatitis core antigen will not be eligible for trial enrollment; participants who are hepatitis C antibody positive, with or without a positive hepatitis C RNA level, will be permitted to enroll in the study provided liver function tests meet criteria, and have no evidence of cirrhosis; participants diagnosed with hepatitis C less than 6 months from trial enrollment, will be considered to have acute hepatitis C and will be excluded from study unless hepatitis (hep) C viral load is undetectable; Creatinine clearance >= 60 mL/min, unless secondary to renal involvement by lymphoma; for creatinine clearance < 50 mL/min due to kidney involvement by tumor; Granulocytes/absolute neutrophil count (ANC) >= 1,000/mm^3; Platelets >= 75,000/mm^3 (unless these parameters are abnormal secondary to lymphomatous involvement of bone marrow); all participants must cease colony-stimulating factor therapy at least 24 hours prior to institution of cycle 1 chemotherapy; Left ventricular ejection fraction (LVEF) that is at or above the lower institutional limits of normal, as assessed by multiple gated acquisition (MUGA) scan or echocardiogram within the 6 weeks prior to registration; Concurrent radiation, with or without steroids, or steroids alone for emergency conditions secondary to lymphoma (i.e. cord compression, etc.) will be permitted; Female participants must have a negative pregnancy test within 7 days of entering into the study; both men and women of child bearing potential must agree to use adequate methods of contraception for the duration of the treatment; women must avoid pregnancy, and men must avoid fathering children while in the study and for 6 months following the last study drug treatment; Participants on an antiretroviral regimen should be receiving treatment that is in accordance with the current International acquired immune deficiency syndrome (AIDS) Society guidelines; the specific agents are at the discretion of the investigator and use of agents currently available on an expanded access basis is allowed but use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) are prohibited; changes to highly active anti-retroviral therapy (HAART) therapy may be made if medically necessary (toxicity, failure of regimen, etc.); antiretroviral naïve participants: participants who are not on HAART at study entry MUST begin therapy (utilizing the above guidelines) AFTER one cycle of chemotherapy has been completed under protocol; changes to HAART therapy may be made if medically necessary (toxicity, failure of regimen, etc.); concurrent therapy with zidovudine or a zidovudine-containing regimen (including Combivir and Trizivir) will be prohibited until 2 months following the participant's completion of chemotherapy as part of this protocol; the use of cobicistat (e.g., Tybost), or cobicistat containing single tablet regimens (e.g., Stribild) is prohibited during concurrent chemotherapy under this protocol; participants taking cobicistat or cobicistat-containing single table regimens must switch to a different agent or regimen prior to enrollment, and will remain on the regimen until at least 2 months following treatment discontinuation; Cobicistat is a pure and potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor and has the potential to increase the area under the curve (AUC) of CYP3A4 substrates; therefore, both vincristine and doxorubicin would have the potential for drug drug interaction (DDI) with cobicistat since they are CYP3A4 substrates; Participants already receiving erythropoietin or colony-stimulating factor therapy are eligible for participation, although the latter must be discontinued at least 24 hours prior to receiving chemotherapy; Participants must be able to swallow oral medications Exclusion Criteria: Participants who have received more than one (1) prior cycle of chemotherapy similar to cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) or EPOCH with or without rituximab; Absolute CD4 count of < 50 cells/ mm^3; Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma (KS) that requires systemic therapy; Central nervous system (CNS) involvement by lymphoma including parenchymal brain or spinal cord lymphoma or known presence of leptomeningeal disease prior to registration; Participants with viral hepatitis who do not meet the criteria will not be eligible; all participants who present with acute hepatitis B including those with normal transaminases who are HBsAg+ and IgM + for hepatitis core antigen will not be eligible; participants who are hepatitis B core antibody positive are eligible only if they start or are on prophylactic therapy; a hepatitis B viral load should be confirmed negative on all participants who are hepatitis B core antibody positive, but hepatitis B antigen negative; participants refusing to take any anti-hepatitis B therapy during study will also be excluded; participants diagnosed with hepatitis C are eligible if they meet criteria; Pregnant women or nursing mothers; ECOG performance score >= 3 (Karnofsky performance status [KPS] < 50%); Expected survival < 2 months; Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator; Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible; Major surgery, other than diagnostic surgery, occurring 4 weeks prior to study entry; splenectomy will not be considered an exclusionary major surgery; Rituximab therapy within the 12 months prior to study entry; participants treated with rituximab within 12 months prior to study registration are eligible only if it was given for indications other than the treatment of aggressive lymphoma; Prior cytotoxic chemotherapy or radiotherapy for this lymphoma; History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past; Use of zidovudine or cobicistat as part of the HAART regimen (a drug substitution at the time of study entry is allowed); Any acute, inter-current infection that may interfere with planned protocol treatment; participants with mycobacterium avium will not be excluded from study entry; chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met; Myocardial infarction (MI) within 6 months prior to study entry, New York Heart Association (NYHA) class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities; Participants should not have taken valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to study enrollment
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01193842
Other Study ID Numbers ICMJE	NCI-2011-02508; NCI-2011-02508 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); AMC #75; CDR0000683379; AMC-075 ( Other Identifier: AIDS Malignancy Consortium ); AMC-075 ( Other Identifier: DCP ); AMC-075 ( Other Identifier: CTEP ); UM1CA121947 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Cancer Institute (NCI)
Study Sponsor ICMJE	National Cancer Institute (NCI)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Juan Ramos AIDS Malignancy Consortium
PRS Account	National Cancer Institute (NCI)
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP