An observational study in HIV Infection, Human Immunodeficiency Virus 1 Positive and Malignant Neoplasm, sponsored by AIDS Malignancy Consortium. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by AIDS Malignancy Consortium · Observational
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 175 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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:
Exclusion Criteria:
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
Other: Medical Chart Review · Other: Survey Administration
Correlative studies
Also known as: Chart Review
Respond to surveys
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21 months
Information on the Use of Diagnostic Testing in HIV-positive Individuals
The frequency of diagnostic testing modalities will be summarized for cancer.
Time frame: 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.
Time frame: 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.
Time frame: Up to 21 months
CD4 of HIV-positive Individuals Diagnosed With Cancer
CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.
Time frame: Baseline
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized
Time frame: Baseline
| Milestone | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Started | 175 |
| Completed | 175 |
| Not completed | 0 |
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.
| Participants | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| 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 |
| Hospital Roffo (surveillance) | 4 |
| Instituto Nacional De Cancer Brazil (new diagnosis) | 11 |
| Instituto Nacional De Cancer Brazil (recurrence) | 2 |
| Instituto Nacional De Cancer Brazil (surveillance) | 9 |
| Instituto de Oncologia (new diagnosis) | 27 |
| Instituto de Oncologia (recurrence) | 9 |
| Instituto de Oncologia (surveillance) | 64 |
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.
| New diagnosis cases per month | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| 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) |
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 | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| 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) |
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 | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| 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) |
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.
| Mean cases per month | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Kaposi sarcoma | 2.14 (1.56 to 2.87) |
| non-Hodgkin's Lymphoma | 1.33 (0.89 to 1.93) |
| Hodgkin's Lymphoma | 0.38 (0.16 to 0.75) |
| Anal cancer | 0.14 (0.03 to 0.42) |
| Cervical cancer | 0.14 (0.03 to 0.42) |
| Other | 1.14 (0.73 to 1.70) |
The frequency of diagnostic testing modalities will be summarized for cancer.
| Participants | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Histology (Kaposi sarcoma) | 62 |
| Clinical only (Kaposi sarcoma) | 7 |
| Histology (Non-Hodgkin's lymphoma) | 45 |
| Cytology (Non-Hodgkin's lymphoma) | 1 |
| Histology (Hodgkin's lymphoma) | 12 |
| Cytology (Hodgkin's lymphoma) | 1 |
| Histology(Anal) | 3 |
| Histology (Cervical) | 5 |
| Histology (Other) | 38 |
| Unknown | 1 |
For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.
| Participants | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Kaposi sarcoma (NNRTI only) | 17 |
| Kaposi sarcoma (Combination) | 48 |
| Kaposi sarcoma (No HIV treatment) | 5 |
| Non-Hodgkin's lymphoma (NNRTI only) | 18 |
| Non-Hodgkin's lymphoma (Combination) | 25 |
| Non-Hodgkin's lymphoma (No HIV treatment) | 3 |
| Hodgkin's lymphoma (NNRTI only) | 4 |
| Hodgkin's lymphoma (Combination) | 8 |
| Hodgkin's lymphoma (No HIV treatment) | 1 |
| Anal (NNRTI only) | 1 |
| Anal (Combination) | 2 |
| Cervical (Combination) | 4 |
| Cervical (No HIV treatment) | 1 |
| Other (NNRTI only) | 21 |
| Other (Combination) | 12 |
| Other (No HIV treatment) | 5 |
The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized.
| Participants | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Surgery only | 3 |
| surgery and chemotherapy | 2 |
| Radiation only | 2 |
| Radiation and chemotherapy | 3 |
| Chemotherapy only | 24 |
| Chemotherapy and other | 1 |
| Other | 11 |
| No information | 129 |
CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.
| Percentage of CD4 cells | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Kaposi sarcoma | 15 (8 to 22) |
| Non-Hodgkin's lymphoma | 14.5 (9 to 25) |
| Hodgkin's lymphoma | 17 (16 to 24) |
| Anal | 18 (13 to 24) |
| Cervical | 18 (16 to 24) |
| Other | 26 (18 to 35) |
HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized
| copies per ml | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Kaposi sarcoma | 46 (40 to 1125) |
| Non-Hodgkin's lymphoma | 40.5 (40 to 29246) |
| Hodgkin's lymphoma49 | 49 (40 to 364) |
| Anal | 30 (20 to 40) |
| Cervical | 40.5 (40 to 41) |
| Other | 40 (40 to 47) |
Collected over Adverse event data were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observational (Respond to Surveys, Medical Record Review) | — | — | — |
| Age, Categorical(Participants) | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 167 |
| >=65 years | 8 |
| Age, Continuous(years) | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Median | 39 (33 to 50) |
| Sex: Female, Male(Participants) | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Female | 37 |
| Male | 138 |
| Ethnicity (NIH/OMB)(Participants) | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Hispanic or Latino | 171 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 13 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 47 |
| More than one race | 0 |
| Unknown or Not Reported | 100 |
| Region of Enrollment(participants) | Observational (Respond to Surveys, Medical Record Review) |
|---|---|
| Argentina | 26 |
| Brazil | 49 |
| Mexico | 100 |
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AIDS Malignancy Consortium