HIV InfectionNCT04089488

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

An observational study of HIV Infection and Human Immunodeficiency Virus 1 Positive, run by AIDS Malignancy Consortium at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection, Human Immunodeficiency Virus 1 Positive, Malignant Neoplasm
What is being tested?: Medical Chart Review and Survey Administration
How many people: 175 participants
Where: 4 sitesin 3 countries
Study dates: 17 Jan 2020to 18 Oct 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

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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.

Who cannot join

Participants not meeting all criteria above are ineligible.

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Brazil2 sites

Instituto Nacional de Câncer José de Alencar
Rio de Janeiro, 20231-050
Complexo Hospitalar Universitário Professor Edgard Santos
Salvador

Other trials in Brazil

Argentina1 site

Hospital de Agudos Juan A. Fernandez
Buenos Aires

Other trials in Argentina

Mexico1 site

Instituto Nacional de Cancerologia
Mexico City, 14080

Other trials in Mexico

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

Conditions: HIV Infection, Human Immunodeficiency Virus 1 Positive, Malignant Neoplasm, Recurrent Malignant Neoplasm
Being tested: Medical Chart Review, Survey Administration
Medical subject headings: HIV Infections, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical Chart ReviewOther
Also called Chart Review
Correlative studies
Survey AdministrationOther
Respond to surveys

Study groups in NCT04089488
Study group	Role	What they receive
Observational (respond to surveys, medical record review)		Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Receives: Other: Medical Chart Review; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 21 months
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.
Measured: 21 months
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.
Measured: 21 months
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.
Measured: 21 months
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.
Measured: 21 months

Secondary outcomes (5)

Information on the Use of Diagnostic Testing in HIV-positive Individuals
The frequency of diagnostic testing modalities will be summarized for cancer.
Measured: Up to 21 months
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.
Measured: Up to 21 months
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.
Measured: Up to 21 months
CD4 of HIV-positive Individuals Diagnosed With Cancer
CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.
Measured: Baseline
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 202018 Oct 2021

First posted13 Sep 2019
Study start17 Jan 2020
Primary completion18 Oct 2021
Study completion18 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04089488
Sponsor's protocol ID: AMC-S008
Other IDs: NCI-2019-01734, AMC-S008, AMC-S008, UM1CA121947
Status last verified: Aug 2023
First submitted: 12 Sep 2019
Last updated: 1 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
ClinicalTrials.gov ID: NCT04089488
Acronym / sponsor ID: AMC-S008
Conditions: HIV Infection, Human Immunodeficiency Virus 1 Positive, Malignant Neoplasm, Recurrent Malignant Neoplasm
Study type: Observational
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: AIDS Malignancy ConsortiumResearch network
Collaborators: National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas
Study start: 17 Jan 2020 (actual)
Primary completion: 18 Oct 2021 (actual)
Study completion: 18 Oct 2021 (actual)
First posted: 13 Sep 2019 (actual)
Results: Posted 22 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

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.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational (respond to surveys, medical record review)	–	Other: Medical Chart Review, Other: Survey AdministrationPatients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (12 listed)

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

Key exclusion criteria (1 listed)

Participants not meeting all criteria above are ineligible.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medical Chart ReviewAlso: Chart ReviewCorrelative studies	Other	Observational (respond to surveys, medical record review)
Survey AdministrationRespond to surveys	Other	Observational (respond to surveys, medical record review)

Primary outcome

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
Time frame: Up to 21 months
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.
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Time frame: 21 months
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.
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Time frame: 21 months
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.
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Time frame: 21 months
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.
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Time frame: 21 months
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.

5 secondary outcomes

Information on the Use of Diagnostic Testing in HIV-positive Individuals
Time frame: Up to 21 months
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Time frame: Up to 21 months
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Time frame: Up to 21 months
CD4 of HIV-positive Individuals Diagnosed With Cancer
Time frame: Baseline
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Time frame: Baseline

Results and safety

Results posted to the registry on 22 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational (Respond to Surveys, Medical Record Review)	175	175

Primary outcome: 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

Time frame: Up to 21 months. Count of participants. Unit: Participants

Measure	Observational (Respond to Surveys, Medical Record Review) n = 175
Complexo Hospitalar Professor Edgard Santos (new diagnosis)	13
Complexo Hospitalar Professor Edgard Santos (recurrence)	4
Complexo Hospitalar Professor Edgard Santos (surveillance)	10
Hospital Fernandez (new diagnosis)	10
Hospital Fernandez (recurrence)	2
Hospital Fernandez (surveillance)	5
Hospital Roffo (new diagnosis)	3
Hospital Roffo (recurrence)	2

Population analysed: 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.

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

Time frame: 21 months. Mean (95% Confidence Interval). Unit: New diagnosis cases per month

Measure	Observational (Respond to Surveys, Medical Record Review) n = 175
Complexo Hospitalar Professor Edgard Santos (new diasgnosis)	0.62 (0.33 to 1.06)
Instituto Nacional De Cancer Brazil (new diagnosis)	0.52 (0.26 to 0.94)
Instituto de Oncologia (new diagnosis)	1.29 (0.84 to 1.87)
Hospital Fernandez (new diagnosis)	0.48 (0.23 to 0.88)
Hospital Roffo (new diagnosis)	0.14 (0.03 to 0.42)

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

Time frame: 21 months. Mean (95% Confidence Interval). Unit: Mean cases per month

Measure	Observational (Respond to Surveys, Medical Record Review) n = 175
Kaposi sarcoma (new diagnosis)	1.19 (0.77 to 1.75)
Non-Hodgkin's Lymphoma (new diagnisis)	0.86 (0.51 to 1.35)
Hodgkin's lymphoma (new diagnosis)	0.24 (0.08 to 0.56)
Anal cancer (new diagnosis)	0 (0 to 0)
Cervical cancer (new diagnosis)	0.10 (0.01 to 0.34)
Other (new diagnosis)	0.67 (0.36 to 1.12)

Population analysed: The numbers of participants per cancer type were displayed.

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

Time frame: 21 months. Mean (95% Confidence Interval). Unit: mean cases per month

Measure	Observational (Respond to Surveys, Medical Record Review) n = 175
Complexo Hospitalar Professor Edgard Santos	.67 (.36 to 1.12)
Instituto Nacional De Cancer Brazil	0.52 (0.26 to 0.94)
Instituto de Oncologia	3.48 (2.72 to 4.37)
Hospital Fernandez	0.33 (0.13 to 0.69)
Hospital Roffo	0.29 (0.10 to 0.62)

Population analysed: The numbers of participants per study site were displayed.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational (Respond to Surveys, Medical Record Review)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for HIV Infection

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert M Strother principal investigator

AIDS Malignancy Consortium

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection and Human Immunodeficiency Virus 1 Positive, run by AIDS Malignancy Consortium at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Brazil, Argentina, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 21 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.