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Incidence of HANA Conditions in HIV-infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03483584
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
Grace Lui, Chinese University of Hong Kong

Brief Summary:

With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical management. It is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of HANA conditions.

This study aims to evaluate the incidence of various HANA conditions in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The incidence of various HANA conditions will be evaluated for those receiving INSTI versus other non-INSTI-based regimens.

The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance 3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7. Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA condition will be determined and compared between those initiated different anti-retroviral regimens.

Condition or disease
HIV Metabolic Syndrome Osteopenia Osteoporosis Vitamin D Deficiency Renal Impairment Liver Fibroses

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Longitudinal Cohort Study to Determine the Incidence of HIV-associated Non-AIDS Conditions in Newly Diagnosed HIV-infected Individuals Initiating Integrase Inhibitor-based and Other Anti-retroviral Regimens
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. HANA incidence [ Time Frame: 96 weeks ]
    The incidence rates of HANA conditions which will be assessed.

Biospecimen Retention:   Samples Without DNA
Peripheral blood samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newly diagnosed HIV-infected patients meeting inclusion criteria, who attend the government HIV clinic, which is the largest HIV clinic in Hong Kong, over a 12-month period, will be invited to participate in this study. Subjects will also be referred by non-governmental organizations providing support to HIV-infected individuals at the time of diagnosis.

Inclusion Criteria:

  1. Confirmed HIV infection by HIV antibody or RNA test
  2. Age ≥40 years old
  3. Anti-retroviral treatment naïve
  4. Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician

Exclusion Criteria:

  1. Pregnancy
  2. Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03483584

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Contact: Rity Wong +85235053376
Contact: Grace Lui +85235051464

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Hong Kong
Prince of Wales Hospital Recruiting
Sha Tin, Hong Kong
Contact    35056000      
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Grace Lui CUHK

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Responsible Party: Grace Lui, Clinical Assistant Professor, Chinese University of Hong Kong Identifier: NCT03483584    
Other Study ID Numbers: HANA protocol v.1 10Oct2017
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Liver Cirrhosis
Renal Insufficiency
Metabolic Syndrome
Vitamin D Deficiency
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Deficiency Diseases
Nutrition Disorders
Liver Diseases
Digestive System Diseases