NCT04667026

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jan 2009May 2031

Study Start

First participant enrolled

January 1, 2009

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2031

Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

22 years

First QC Date

November 19, 2020

Last Update Submit

September 12, 2022

Conditions

HIV Infections

Keywords

HIV/AIDSART

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The CD4+T cell counts after ART.

    Year 10

  • All-cause mortality among HIV/AIDS after ART.

    Year 10

  • The incidence of adverse reactions after ART.

    Year 10

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with HIV/AIDS who are willing to receive antiretroviral therapy.

You may qualify if:

  • Patients has a history of diagnosis of HIV.
  • Receiving antiretroviral therapy.
  • Good treatment compliance.

You may not qualify if:

  • Aged less than 14 years of old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During the study, the blood sample of patients should be preserved to detect the HIV RNA load , other co-infected microbes and drug toxicity.

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Ling-Hua Li, doctor

    Guangzhou Eighth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linghua Li, MD,PhD

CONTACT

llheliza@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice chief of Infectious Disease Center

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 14, 2020

Study Start

January 1, 2009

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

May 31, 2031

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

CN(1)