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NCT Number: NCT04742387

Assessment of Bone Mineral Density in People Living With HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis

Background:

Some people with human immunodeficiency virus (HIV) are on antiretroviral therapy (ART). Their cells have shown to age faster than expected. This puts them at higher risk for a range of age-related diseases about 10 years sooner than people who do not have HIV. Low bone mineral density (BMD) is common in people with HIV. This means their risk of fractures is increased. People with HIV also have a higher risk for cancers caused by Kaposi's sarcoma herpesvirus (KSHV) than people who do not have HIV. Much of the data on bone loss related to cancer and cancer treatments has been gathered from people who do not have HIV. Researchers want to learn more about the rate of bone loss in people with HIV/AIDS and KSHV associated cancers.

Objective:

To learn the factors that are linked to BMD loss in people with HIV and KSHV associated cancers from imaging performed as part of NIH studies.

Eligibility:

Adults with HIV and Kaposi s sarcoma who got ART and cancer chemotherapy at NIH from 1/1/2005 to 12/1/2020.

Design:

Participants' records will be chosen from studies that were conducted from 1/1/2005 to 12/1/2020. This study will include participants who had at least 2 CT scans. Some participants may have opted out of the future use of their data. If so, their records will not be used.

This study will use data collected at NIH. Data taken from CT scans will be used to measure BMD.

Study results may be published.

This study will last about 2 years.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Kaposi Sarcoma Acquired Immunodeficiency Syndrome Blood-Borne Infections Bone Diseases Bone Diseases, Metabolic Communicable Diseases DNA Virus Infections Genital Diseases HIV Infections Hemic and Lymphatic Diseases Herpesviridae Infections IL-6 Related KSHV Associated Cytokine Syndrome Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections KSHV Associated Multicentric Castleman Disease Lentivirus Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma, Primary Effusion Lymphoproliferative Disorders Metabolic Diseases Multi-centric Castleman's Disease Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Nutritional and Metabolic Diseases Primary Effusion Lymphoma RNA Virus Infections Retroviridae Infections Sarcoma Sarcoma, Kaposi Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

About this study

Title:

Assessment of Bone Mineral Density in People Living with HIV and KSHV Associated Malignancies: A Retrospective Longitudinal Analysis

Study Description:

This is a retrospective review that includes all participants with human immunodeficiency virus (HIV) (PWH) affected by Kaposi sarcoma (KS), KSHV-associated multicentric Castleman disease, and KSHV associated inflammatory cytokine syndrome enrolled on the tissue procurement study (01-C-0038) and other treatment protocols within the HIV/AIDS Malignancy Branch at the National Cancer Institute (NCI) from 1/1/2005 to 12/1/2020.

Objectives:

To determine the factors that are associated with bone mineral density (BMD) loss in PWH and KSHV associated malignancies.

Study Population:

All patients seen at the NIH from 1/1/2005 to 12/1/2020.

Description of Sites/Facilities conducting research:

This is a single site study initiated by the HIV/AIDS Malignancy Branch at the National Cancer Institute

Study Duration:

Data abstraction to completion of data analyses will take about 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

STUDY POPULATION:

Subjects will not be recruited for this study; however, participants' records will be selected from treatment protocols from 1/1/2005 to 12/1/2020 unless the subject opted out of the future use of his/her data. These subjects enrolled to natural history and/or treatment protocols within the HIV/AIDS Malignancy Branch on the basis of a diagnosis of HIV and KSHV-associated conditions, such as KS alone, in combination with KSHV-MCD or KICS.

As this is a retrospective longitudinal study, the investigators will review the data from subjects who have at least two completed CT scans to measure bone mineral density.

Treatment and study plan

Primary outcomes

BMD loss

Time frame: ongoing

To determine variables that are associated with BMD loss in participants with HIV and KSHV associated malignancies from retrospective imaging performed as part of clinical research protocols

Secondary outcomes

longitudinal change in BMD

Time frame: ongoing

To estimate the longitudinal change in BMD from study baseline

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Feb 8, 2021
Registry last updated: Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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