HIV InfectionsOSPWHNCT04667026
Observational Study on Patients With HIV/AIDS(OSPWH)
An observational study of HIV Infections, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
To establish a follow-up cohort of antiretroviral therapy(ART) for patients with HIV/AIDS, to observe the ART efficacy and adverse reactions, complications in the process of ART, as well as mortality and causes of death, so as to provide basis for further improving ART efficacy and quality of life of the patients. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 31 May 2031
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with HIV/AIDS who are willing to receive antiretroviral therapy.
Who may be able to join
- Patients has a history of diagnosis of HIV.
- Receiving antiretroviral therapy.
- Good treatment compliance.
Who cannot join
- Aged less than 14 years of old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Linghua Li, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510060
Linghua Li, MD, PhD
About this study
Official title: Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS
To establish a follow-up cohort of antiretroviral therapy(ART) for patients with HIV/AIDS, to observe the ART efficacy and adverse reactions, complications in the process of ART, as well as mortality and causes of death, so as to provide basis for further improving ART efficacy and quality of life of the patients.
Read the detailed description
- To establish a follow-up cohort of ART for HIV/AIDS patients: follow-up points: before treatment and 1, 2, 3 months after treatment, and every 3 months after treatment.
- To observe the ART efficacy and adverse reactions: The clinical manifestations, laboratory and auxiliary examination indexes of each follow-up time point was observed in the follow-up cohort, including blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, plasma HIV RNA,CD4 cell count, hepatitis index and syphilis index, etc. If HIV RNA is more than 1000 copies/ml, after treatment for more than 6 months, peripheral blood 10ml should be retained and drug resistance should be detected.
- To investigate the complications of HIV/AIDS patients before and after ART.
- To investigate the mortality and causes of death in patients with HIV/AIDS.
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, ART
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of virological suppression after antiretroviral therapy.
After ART, HIV RNA level in plasma were quantified every year. The rate of HIV-RNA<400 copies/ml will be used to evaluate the efficacy of ART and the variation tendency of the rate of virological suppression will be described.
Measured: Year 10
Secondary outcomes (3)
The CD4+T cell counts after ART.
The CD4+T cell count in plasma were detected every 3 months. The variation tendency of CD4+Tcell count will be described.
Measured: Year 10
All-cause mortality among HIV/AIDS after ART.
Describe the all-cause mortality among HIV/AIDS after ART and analyze the trend.
Measured: Year 10
The incidence of adverse reactions after ART.
In order to assess the adverse reactions after ART, the clinical symptoms were recorded, such as respiratory symptoms, digestive system symptoms, nervous system symptoms, and mental symptoms, etc. And cytological and biochemical indexes were detected such as blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, etc. Calculate the incidence of adverse reactions after ART for 10 years.
Measured: Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Jan 2009
- Primary completion31 Dec 2030 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linghua LI, Guangzhou 8th People's Hospital
- Investigators
- Ling-Hua Li, doctor, Principal investigator, Guangzhou Eighth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667026
- Sponsor's protocol ID
- GZ8HART-v1, 20200910
- Acronym
- OSPWH
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin W, He Y, Gu F, Hu F, Yu H, Li H, Liu C, Tang X, Cai W, Li L. Hepatic Flare Following Effective Antiretroviral Therapy Is Associated With HBsAg Seroclearance in HBV/HIV-1 Co-Infection. J Med Virol. 2024 Dec;96(12):e70114. doi: 10.1002/jmv.70114.
PubMed 39654313
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS
- ClinicalTrials.gov ID
- NCT04667026
- Acronym / sponsor ID
- OSPWH / GZ8HART-v1, 20200910
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, ART
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 14 Dec 2020 (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.
To establish a follow-up cohort of antiretroviral therapy(ART) for patients with HIV/AIDS, to observe the ART efficacy and adverse reactions, complications in the process of ART, as well as mortality and causes of death, so as to provide basis for further improving ART efficacy and quality of life of the patients.
Detailed description
- To establish a follow-up cohort of ART for HIV/AIDS patients: follow-up points: before treatment and 1, 2, 3 months after treatment, and every 3 months after treatment.
- To observe the ART efficacy and adverse reactions: The clinical manifestations, laboratory and auxiliary examination indexes of each follow-up time point was observed in the follow-up cohort, including blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, plasma HIV RNA,CD4 cell count, hepatitis index and syphilis index, etc. If HIV RNA is more than 1000 copies/ml, after treatment for more than 6 months, peripheral blood 10ml should be retained and drug resistance should be detected.
- To investigate the complications of HIV/AIDS patients before and after ART.
- To investigate the mortality and causes of death in patients with HIV/AIDS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HIV/AIDS who are willing to receive antiretroviral therapy.
Key inclusion criteria (3 listed)
- Patients has a history of diagnosis of HIV.
- Receiving antiretroviral therapy.
- Good treatment compliance.
Key exclusion criteria (1 listed)
- Aged less than 14 years of old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of virological suppression after antiretroviral therapy.
Time frame: Year 10
After ART, HIV RNA level in plasma were quantified every year. The rate of HIV-RNA<400 copies/ml will be used to evaluate the efficacy of ART and the variation tendency of the rate of virological suppression will be described.
3 secondary outcomes
The CD4+T cell counts after ART.
Time frame: Year 10
All-cause mortality among HIV/AIDS after ART.
Time frame: Year 10
The incidence of adverse reactions after ART.
Time frame: Year 10
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 14 Sep 2022.
- Derived from this study: PubMed 39654313Lin W, He Y, Gu F, Hu F, Yu H, Li H, Liu C, Tang X, Cai W, Li L. Hepatic Flare Following Effective Antiretroviral Therapy Is Associated With HBsAg Seroclearance in HBV/HIV-1 Co-Infection. J Med Virol. 2024 Dec;96(12):e70114. doi: 10.1002/jmv.70114.
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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.
Linghua Li, MD,PhD contact
Ling-Hua Li, doctor principal investigator
Guangzhou Eighth People's Hospital
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 HIV Infections, run by Guangzhou 8th People's Hospital at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 14 Sep 2022. 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 China. 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 Linghua Li, MD,PhD (llheliza@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of virological suppression after antiretroviral therapy. (time frame: Year 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667026, which also lists 1 linked publication.
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 14 Sep 2022.