Observational Study on Patients With HIV/AIDS(OSPWH)

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT04667026
• Lead Sponsor: Guangzhou 8th People's Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-14
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14
• Primary Completion: 2030-12-31
• Study Completion: 2031-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of virological suppression after antiretroviral therapy.	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.

Secondary Outcome Measures

Name	Time	Method
The CD4+T cell counts after ART.	Year 10	The CD4+T cell count in plasma were detected every 3 months. The variation tendency of CD4+Tcell count will be described.
The incidence of adverse reactions after ART.	Year 10	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.
All-cause mortality among HIV/AIDS after ART.	Year 10	Describe the all-cause mortality among HIV/AIDS after ART and analyze the trend.

Trial Locations

Locations (1)

Guangzhou Eighth People's Hospital; 🇨🇳 Guangzhou, Guangdong, China