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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089488
• Other study ID #: AMC-S008
• Secondary ID: NCI-2019-01734AM
• Status: Completed
• Start date: January 17, 2020
• Est. completion date: October 18, 2021

Study information

• Verified date: August 2023
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV positive. Documentation of HIV-1 infection by means of any one of the following:

• Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name);

• HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL, and confirmed by a licensed screening antibody and/or HIV antibody/antigen combination assay;

• Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay, such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.

• Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally.

• WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/Custom Industrial Analysis (CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.

• Must have a current or prior (within the last 5 years) diagnosis of cancer, but there is no restriction of the number or type of prior treatments. Participants will qualify under one of three categories:

• New diagnosis: no prior treatment for current malignancy. May be prior to, or currently receiving the first line of therapy.

• Prior diagnosis (within 5 years), in remission: Not currently on cancer treatment other than combination antiretroviral therapy (cART). Prior treatment for malignancy can include surgery, radiation, or chemotherapy (or cART initiation in Kaposi sarcoma [KS]). No restriction on number of prior lines of therapy.

• Prior diagnosis, recurrent: considering or currently receiving treatment that is not first line. No restriction on the number of prior lines of therapy.

• Date of birth and age should be determined based on best possible information or documentation available.

• Ability to understand and the willingness to provide informed consent document.

Exclusion Criteria:

• Participants not meeting all criteria above are ineligible.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Human Immunodeficiency Virus 1 Positive
• Malignant Neoplasm
• Neoplasms
• Recurrence
• Recurrent Malignant Neoplasm

Intervention

Other:
• Medical Chart Review
Correlative studies
• Survey Administration
Respond to surveys

Locations

Country	Name	City	State
Argentina	Hospital de Agudos Juan A. Fernandez	Buenos Aires
Brazil	Instituto Nacional de Câncer José de Alencar	Rio De Janeiro
Brazil	Complexo Hospitalar Universitário Professor Edgard Santos	Salvador
Mexico	Instituto Nacional de Cancerologia	Ciudad de Mexico

Sponsors (4)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas

Countries where clinical trial is conducted

Argentina,  Brazil,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 21 months
Primary	Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by 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 study site.	21 months
Primary	Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.	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.	21 months
Primary	Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by 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 study site.	21 months
Primary	Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by 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 cancer type.	21 months
Secondary	Information on the Use of Diagnostic Testing in HIV-positive Individuals	The frequency of diagnostic testing modalities will be summarized for cancer.	Up to 21 months
Secondary	HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer	For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.	Up to 21 months
Secondary	Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals	The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized.	Up to 21 months
Secondary	CD4 of HIV-positive Individuals Diagnosed With Cancer	CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.	Baseline
Secondary	HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer	HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized	Baseline