Clinical trial NCT04089488: Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America
Official title: Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Human Immunodeficiency Virus 1 Positive
Malignant Neoplasm
Recurrent Malignant Neoplasm
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
name: University of Arkansas
First posted: 2019-09-13
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants presenting to HIV treatment programs or cancer treatment programs at collaborating sites, with both HIV and cancer, which may include either a history of malignancy or current diagnosis

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 21 months
measure: Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
timeFrame: 21 months
measure: Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
timeFrame: 21 months
measure: Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
timeFrame: 21 months
measure: Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
timeFrame: 21 months
Secondary outcomes:
measure: Information on the Use of Diagnostic Testing in HIV-positive Individuals
timeFrame: Up to 21 months
measure: HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
timeFrame: Up to 21 months
measure: Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
timeFrame: Up to 21 months
measure: CD4 of HIV-positive Individuals Diagnosed With Cancer
timeFrame: Baseline
measure: HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
timeFrame: Baseline
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital de Agudos Juan A. Fernandez
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José de Alencar
city: Salvador
country: Brazil
facility: Complexo Hospitalar Universitário Professor Edgard Santos
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
Study officials:
affiliation: AIDS Malignancy Consortium
name: Robert M Strother
role: PRINCIPAL_INVESTIGATOR
References: