Viral ControlNCT07131826
The Quality of Life and Viral Control Effect of AIDS Patients After Long-acting Injection of Cabotegravir and Rilpivirine
An observational study of Viral Control and Quality of Life, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Viral Control, Quality of Life, Cabotegravir
- What is being tested?
- Observational study, non-interventional
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males or females aged 18 years or older who have completed long-acting injectable treatment for HIV infection.
Who may be able to join
- 18 years and above Clinical diagnosis of HIV infection completed long-acting injectable treatment Accept the questionnaire
Who cannot join
- Not clinical diagnosis of HIV infection Do not accept questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
NTUH
Taipei
WANG-HUEI SHENG, +886-02-2312-3456, ntuhrec@ntuh.gov.tw
About this study
"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.
- Conditions
- Viral Control, Quality of Life, Cabotegravir, Rilpivirine, AIDS
- Being tested
- Observational study, non-interventional
- Keywords
- cabotegravir, rilpivirine, AIDS, quality of life, viral control
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, non-interventionalOther
Observational study, non-interventional
| Study group | Role | What they receive |
|---|---|---|
| AIDS patients after long-acting injection of cabotegravir and rilpivirine | AIDS patients after long-acting injection of cabotegravir and rilpivirine Receives: Other: Observational study, non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
To whether long-acting injections can significantly improve the quality of daily life of people infected with HIV using a questionnaire
Measured: From the date of approval by the CTC to December 31, 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Clinical Trial Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor-investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131826
- Sponsor's protocol ID
- 202503037RINA
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Does the long-acting injection improve the quality of daily life of HIV-infected people?
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quality of Life and Viral Control Effect of AIDS Patients After Long-acting Injection of Cabotegravir and Rilpivirine
- ClinicalTrials.gov ID
- NCT07131826
- Acronym / sponsor ID
- 202503037RINA
- Conditions
- Viral Control, Quality of Life, Cabotegravir, Rilpivirine, AIDS
- Keywords
- cabotegravir, rilpivirine, AIDS, quality of life, viral control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University Clinical Trial CenterUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIDS patients after long-acting injection of cabotegravir and rilpivirine | – | Other: Observational study, non-interventionalAIDS patients after long-acting injection of cabotegravir and rilpivirine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males or females aged 18 years or older who have completed long-acting injectable treatment for HIV infection.
Key inclusion criteria (1 listed)
- 18 years and above Clinical diagnosis of HIV infection completed long-acting injectable treatment Accept the questionnaire
Key exclusion criteria (1 listed)
- Not clinical diagnosis of HIV infection Do not accept questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, non-interventionalObservational study, non-interventional | Other | AIDS patients after long-acting injection of cabotegravir and rilpivirine |
Primary outcome
To whether long-acting injections can significantly improve the quality of daily life of people infected with HIV using a questionnaire
Time frame: From the date of approval by the CTC to December 31, 2026.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes. Does the long-acting injection improve the quality of daily life of HIV-infected people?
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Control and Quality of Life, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WANG-HUEI SHENG (+886-02-2312-3456, ntuhrec@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To whether long-acting injections can significantly improve the quality of daily life of people infected with HIV using a questionnaire (time frame: From the date of approval by the CTC to December 31, 2026.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.