Observational Study on Patients With HIV/AIDS(OSPWH)

HIV Infections Clinical Trial

— OSPWH  

Official title:

Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667026
• Other study ID #: GZ8HART-v1, 20200910
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: May 31, 2031

Study information

• Verified date: September 2022
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, MD,PhD
• Email: llheliza[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: May 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Locations

Country	Name	City	State
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Year 10
Secondary	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.	Year 10
Secondary	All-cause mortality among HIV/AIDS after ART.	Describe the all-cause mortality among HIV/AIDS after ART and analyze the trend.	Year 10
Secondary	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.	Year 10