Observational Study on Patients With HIV/AIDS(OSPWH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV Infections. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS
Overview
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
1. 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. 2. 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. 3. To investigate the complications of HIV/AIDS patients before and after ART. 4. To investigate the mortality and causes of death in patients with HIV/AIDS.
Primary outcome measures
- The rate of virological suppression after antiretroviral therapy. [Time frame: Year 10]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Patients has a history of diagnosis of HIV.
- Receiving antiretroviral therapy.
- Good treatment compliance.
Exclusion criteria
- Aged less than 14 years of old.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangzhou Eighth People's Hospital — Guangzhou
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. PMID 39654313
Identifiers
NCT: NCT04667026 · GZ8HART-v1, 20200910