Clinical trial · Observational
Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America
Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
NCT04089488CI-TRIAL-00069288completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infection | — | UNRESOLVED | — |
| Human Immunodeficiency Virus 1 Positive | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Recurrent Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical Chart Review | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (respond to surveys, medical record review)
- description
- Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.
- interventionNames
- Other: Medical Chart Review
- Other: Survey Administration
Primary outcomes (5)
- 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
- description
- 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.
- measure
- Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.