Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Recurrence

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Virus Diseases

Syndrome

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Slow Virus Diseases

Disease Attributes

Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.

Medical Chart Review

Survey Administration

Robert M Strother

This trial studies the frequency of incident and prevalent of cancer in people living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) at cancer centers in Latin America. By counting how many people living with HIV/AIDS have cancer at these specific centers, researchers may better understand how they are being treated and cared for. This may help researchers to understand what new studies may be helpful for those areas in the future.

PRIMARY OBJECTIVES:

I. To determine the number of diagnosed cancers in people living with HIV/AIDS (PLWHA) presenting to participating clinical sites in Latin America, and estimate site-specific prevalence based on all presenting cancers (new diagnosis, recurrence, and surveillance cases) and site-specific incidence based on newly diagnosed cancers.

SECONDARY OBJECTIVES:

I. Obtain information on the use of diagnostic testing and treatment for the cohort of diagnosed HIV-associated cancer participants.

II. To collect information on participant characteristics for diagnosed HIV-associated cancers (e.g., antiretroviral therapy \[ART\] regimen, current CD4 count, current viral load, etc.).

OUTLINE:

Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.

Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America

Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America

The primary endpoint will be the estimates of site-specific frequency of new diagnosis and existing cases (recurrence and surveillance) presenting with HIV and cancer presenting over 1 year, 9 months (21 months) at the clinical sites.

The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months.

This summary was based on the study site.

The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months.

This summary was based on the cancer type.

The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months.

This summary was based on the study site.

The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months.

This summary was based on the cancer type.

The frequency of diagnostic testing modalities will be summarized for cancer.

For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.

The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized.

CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.

HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized

National Cancer Institute (NCI)

The Emmes Company, LLC

University of Arkansas

AIDS Malignancy Consortium

No participants were assessed for deaths or adverse events.

Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.

Medical Chart Review: Correlative studies

Survey Administration: Respond to surveys

Observational (Respond to Surveys, Medical Record Review)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Argentina

Brazil

Mexico

Region of Enrollment

Deukwoo Kwon

There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis and existing cases(recurrence and surveillance) are summarized.

Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites

Complexo Hospitalar Professor Edgard Santos (new diasgnosis)

Instituto Nacional De Cancer Brazil (new diagnosis)

Instituto de Oncologia (new diagnosis)

Hospital Fernandez (new diagnosis)

Hospital Roffo (new diagnosis)

There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis cases are summarized using cases per month.

Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.

Kaposi sarcoma (new diagnosis)

Non-Hodgkin's Lymphoma (new diagnisis)

Hodgkin's lymphoma (new diagnosis)

Anal cancer (new diagnosis)

Cervical cancer (new diagnosis)

Other (new diagnosis)

The numbers of participants per cancer type were displayed.

Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.

Complexo Hospitalar Professor Edgard Santos

Instituto Nacional De Cancer Brazil

Instituto de Oncologia

Hospital Fernandez

Hospital Roffo

The numbers of participants per study site were displayed.

Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.

Kaposi sarcoma

non-Hodgkin's Lymphoma

Hodgkin's Lymphoma

Anal cancer

Cervical cancer

Other

Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type

Information on the Use of Diagnostic Testing in HIV-positive Individuals

HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer

Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals

Non-Hodgkin's lymphoma

Hodgkin's lymphoma

Anal

Cervical

CD4 of HIV-positive Individuals Diagnosed With Cancer

Hodgkin's lymphoma49

89 participants were assessed for this Outcome Measure.

HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer

Overall Study

Neoplasms

Rare Diseases

Sarcoma

HIV Seropositivity

Sarcoma, Kaposi

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

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.

Montefiore Medical Center

University of Stellenbosch

Weill Medical College of Cornell University

University of California, Los Angeles

Blood and Lymph Conditions

Lymphoma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Plerixafor

Lenograstim

Carmustine

O(6)-benzylguanine

Adjuvants, Immunologic

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Enzyme Inhibitors

C46/CCR5/P140K Lentiviral Vector-transduced Autologous HSPCs

Filgrastim

O6-Benzylguanine

Mazyar Shadman

This pilot phase I trial studies the side effects and best dose of human immunodeficiency virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are then re-infused into the patient. These genetically modified stem cells may help the body make cells that are resistant to HIV infection.

PRIMARY OBJECTIVES:

I. To determine the safety and feasibility of infusing C46/CCR5/P140K lentiviral vector-transduced autologous hematopoietic stem progenitor cells (HSPC) (gene modified, HIV-protected HSPC) after standard first line treatment of lymphoma in patients with HIV infection.

II. To determine the dose of carmustine (BCNU) in combination with O6-benzylguanine (O6BG) that results in selection in vivo of gene-modified HIV resistant cells with minimal toxicity.

III. To estimate the effect of HIV infection on the presence of HIV-resistant blood cells as measured by genetic marking for vector sequences before and after highly active antiretroviral therapy (HAART) interruption.

SECONDARY OBJECTIVES:

I. Evaluate the molecular and clonal composition of gene-modified cells after standard first line treatment.

II. Evaluate the molecular and clonal composition of gene-modified cells after O6BG/BCNU.

III. Determine the correlation between the level of MGMT(P140K) marking with toxicity and response to O6BG/BCNU chemotherapy.

IV. Characterize the toxicity associated with in vivo selection.

V. Describe time to disease progression, progression-free survival, treatment-related mortality, time to neutrophil and platelet recovery, and incidence of infections.

TERTIARY OBJECTIVES:

I. Effect of procedure on the latent HIV reservoir.

II. Effect of procedure on HIV-specific immune reconstitution.

OUTLINE:

MOBILIZATION AND HSPC COLLECTION: Between the second and the last course of planned standard chemotherapy, patients undergo mobilization of peripheral blood stem cells with filgrastim subcutaneously (SC) beginning the day after the last dose of chemotherapy in the previous cycle. If CD34 cell count in peripheral blood at least 24 hours after recovery from nadir is \>= 40 CD34 cells/mcL, patients will undergo apheresis collection the next day. If CD34 cell count is \< 40 CD34 cells/mcL, plerixafor SC will be administered and patients will undergo apheresis collection the next day. Patients undergo apheresis until a total apheresis product of \>= 4.0 x 10\^6 CD34+ cells/kg are collected.

STEM CELL INFUSION: Patients receive CD34+ gene-modified C46/CCR5/P140K lentiviral vector-transduced autologous HSPC intravenously (IV) within 2 to 8 days, but no later than 28 days, after completion of the last cycle of first line treatment for lymphoma.

IN VIVO SELECTION WITH O6-BENZYLGUANINE AND CARMUSTINE: Between 28-180 days after infusion of gene-modified HSPC and after hematopoietic recovery from first line treatment, patients with \>= 1% and \< 10% gene marked cells receive O6-benzylguanine IV over 1 hour, immediately followed by carmustine IV, and followed 7-8 hours later by O6-benzylguanine IV over 1 hour. Treatment continues for an additional course provided that gene marked cells does not meet or exceed 10% of peripheral blood cells and in the absence of unacceptable toxicity.

STRUCTURED TREATMENT INTERRUPTION (STI): Patients achieving \>= 10% gene marked cells for 2 consecutive months following infusion of gene-modified HSPC and with CD4+ cell counts and total lymphocyte counts at baseline begin STI of HAART for up to 12 weeks. Patients resume HAART if one of the following criteria occurs: 1) CD4 count \< 350 cells/mcL or decline in percent CD4+ cells by \> 33% from baseline for three consecutive evaluations; 2) increase in HIV RNA \> 100,000 copies/mL on two consecutive evaluations; 3) 12 weeks have passed since discontinuation of HAART; or 4) at the discretion of the infectious disease (ID) consultant or principal investigator (PI).

\* If patient is not on an efavirenz-containing regimen, HAART is discontinued simultaneously. If patient is on an efavirenz-containing regimen, patients will switch from efavirenz to an integrase inhibitor for at least 2 weeks and then discontinue HAART simultaneously.

After completion of study treatment, patients are followed up for 2 years, every 6 months for 3 years and then annually for 15 years.

HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection

A Clinical Trial of Gene-Modified Stem Cells to Generate HIV-Resistant Cells in Conjunction With Standard Chemotherapy for Treatment of Lymphoma in Patients With HIV Infection

Engraftment of \>= 1% gene modified cells.

Any development of confirmed replication competent lentivirus in any patient receiving gene modified cells during the study will be recorded.

Confirmed insertional mutagenesis in any patient who received gene modified cells during the study

National Heart, Lung, and Blood Institute (NHLBI)

Fred Hutchinson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America	NCT04089488	HIV Infection Human Immunodef... Malignant Neopl... Recurrent Malig...	Medical Chart R... Survey Administ...	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 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
HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection	NCT02343666	Human Immunodef... Stage I Adult H... Stage I Adult N... Stage II Adult ... Stage II Adult ... Stage III Adult... Stage III Adult... Stage IV Adult ... Stage IV Adult ...	C46/CCR5/P140K ... Carmustine Filgrastim Laboratory Biom... O6-Benzylguanin... Plerixafor	18 Years - 66 Years	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for human immunodeficiency virus 1 positive