NCT07131826

Brief Summary

"AIDS" was once regarded as the Black Death of the 20th century. However, with the advent of cocktail therapy, the survival rate of infected people has been greatly improved and the average life expectancy has been increased. Today, AIDS is considered a chronic disease, just like hypertension and diabetes. As long as you have regular checkups and take medication on time every day, you can complete the treatment, just like a normal person. However, there is still a risk of missing medication when taking it every day, and long-term missed medications can easily lead to drug resistance and increase the risk of treatment failure. After the HIV-infected person has stabilized the viral load, their mobility, self-care and daily activities are no different from those of normal people. However, they experience side effects such as fatigue, lack of energy, difficulty sleeping, depression, changes in appearance, tension and anxiety, dizziness, headache, vomiting, etc., which affect their quality of life. The long-acting AIDS injection is a long-acting dosage form for intramuscular injection. It has been included in the national health insurance reimbursement standards. Treatment with long-acting injections can reduce the risk of infected people forgetting to take medicine, and there is no need to worry about the exposure of the disease when storing the medicine. Through this study, we hope to collect the results of long-acting injections for stable HIV treatment cases (health status, daily activities, injection site, satisfaction), and confirm that long-acting injections can significantly improve the quality of daily life of HIV-infected people.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

April 28, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 20, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

April 28, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

cabotegravirrilpivirineAIDSquality of lifeviral control

Outcome Measures

Primary Outcomes (1)

  • To whether long-acting injections can significantly improve the quality of daily life of people infected with HIV using a questionnaire

    From the date of approval by the CTC to December 31, 2026.

Study Arms (1)

AIDS patients after long-acting injection of cabotegravir and rilpivirine

AIDS patients after long-acting injection of cabotegravir and rilpivirine

Other: Observational study, non-interventional

Interventions

Observational study, non-interventional

AIDS patients after long-acting injection of cabotegravir and rilpivirine

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males or females aged 18 years or older who have completed long-acting injectable treatment for HIV infection.

You may qualify if:

  • years and above Clinical diagnosis of HIV infection completed long-acting injectable treatment Accept the questionnaire

You may not qualify if:

  • Not clinical diagnosis of HIV infection Do not accept questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
WANG-HUEI SHENG professor

Study Record Dates

First Submitted

April 28, 2025

First Posted

August 20, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Does the long-acting injection improve the quality of daily life of HIV-infected people?

Shared Documents
STUDY PROTOCOL

Locations