Observational Study on Patients With HIV/AIDS(OSPWH)

NCT ID: NCT04667026

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2031-05-31

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou 8th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linghua LI

Vice chief of Infectious Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling-Hua Li, doctor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Eighth People's Hospital

Locations

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Linghua Li, MD,PhD

Role: CONTACT

llheliza@126.com

Facility Contacts

Linghua Li, MD, PhD

Role: primary

Other Identifiers

GZ8HART-v1, 20200910

Identifier Type: -

Identifier Source: org_study_id