18 and older, any sex, with HIV Infection or Human Immunodeficiency Virus 1 Positive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 SitesPrimary· 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.
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
13
Observational (Respond to Surveys, Medical Record Review)
4
Observational (Respond to Surveys, Medical Record Review)
10
Observational (Respond to Surveys, Medical Record Review)
10
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.Primary· 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.
Complexo Hospitalar Professor Edgard Santos (new diasgnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.62
0.33 – 1.06
Instituto Nacional De Cancer Brazil (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.52
0.26 – 0.94
Instituto de Oncologia (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
1.29
0.84 – 1.87
Hospital Fernandez (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.48
0.23 – 0.88
Hospital Roffo (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.14
0.03 – 0.42
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.Primary· 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.
Kaposi sarcoma (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
1.19
0.77 – 1.75
Non-Hodgkin's Lymphoma (new diagnisis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.86
0.51 – 1.35
Hodgkin's lymphoma (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.24
0.08 – 0.56
Anal cancer (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0
0 – 0
Cervical cancer (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.10
0.01 – 0.34
Other (new diagnosis)
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.67
0.36 – 1.12
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.Primary· 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.
Complexo Hospitalar Professor Edgard Santos
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
.67
.36 – 1.12
Instituto Nacional De Cancer Brazil
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.52
0.26 – 0.94
Instituto de Oncologia
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
3.48
2.72 – 4.37
Hospital Fernandez
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.33
0.13 – 0.69
Hospital Roffo
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.29
0.10 – 0.62
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer TypePrimary· 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.
Kaposi sarcoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
2.14
1.56 – 2.87
non-Hodgkin's Lymphoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
1.33
0.89 – 1.93
Hodgkin's Lymphoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.38
0.16 – 0.75
Anal cancer
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.14
0.03 – 0.42
Cervical cancer
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
0.14
0.03 – 0.42
Other
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
1.14
0.73 – 1.70
Information on the Use of Diagnostic Testing in HIV-positive IndividualsSecondary· Up to 21 months
The frequency of diagnostic testing modalities will be summarized for cancer.
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
62
Observational (Respond to Surveys, Medical Record Review)
7
Observational (Respond to Surveys, Medical Record Review)
45
Observational (Respond to Surveys, Medical Record Review)
1
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With CancerSecondary· Up to 21 months
For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
17
Observational (Respond to Surveys, Medical Record Review)
48
Observational (Respond to Surveys, Medical Record Review)
5
Observational (Respond to Surveys, Medical Record Review)
18
Information on the Treatment for Cancers Diagnosed in HIV-positive IndividualsSecondary· Up to 21 months
The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized.
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
3
Observational (Respond to Surveys, Medical Record Review)
2
Observational (Respond to Surveys, Medical Record Review)
2
Observational (Respond to Surveys, Medical Record Review)
3
CD4 of HIV-positive Individuals Diagnosed With CancerSecondary· Baseline
CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.
Kaposi sarcoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
15
8 – 22
Non-Hodgkin's lymphoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
14.5
9 – 25
Hodgkin's lymphoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
17
16 – 24
Anal
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
18
13 – 24
Cervical
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
18
16 – 24
Other
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
26
18 – 35
HIV Viral Load of HIV-positive Individuals Diagnosed With CancerSecondary· Baseline
HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized
Kaposi sarcoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
46
40 – 1125
Non-Hodgkin's lymphoma
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
40.5
40 – 29246
Hodgkin's lymphoma49
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
49
40 – 364
Anal
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
30
20 – 40
Cervical
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
40.5
40 – 41
Other
Group
Value
95% CI
Observational (Respond to Surveys, Medical Record Review)
40
40 – 47
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by AIDS Malignancy Consortium
Last refreshed: 1 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04089488.