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Observational Study on Patients With HIV/AIDS(OSPWH) (OSPWH)

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ClinicalTrials.gov Identifier: NCT04667026
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Study Description
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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.

Condition or disease
HIV Infections

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 Design
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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS
Actual Study Start Date : January 1, 2009
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : May 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The rate of virological suppression after antiretroviral therapy. [ Time Frame: 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 :
  1. The CD4+T cell counts after ART. [ Time Frame: Year 10 ]
    The CD4+T cell count in plasma were detected every 3 months. The variation tendency of CD4+Tcell count will be described.

  2. All-cause mortality among HIV/AIDS after ART. [ Time Frame: Year 10 ]
    Describe the all-cause mortality among HIV/AIDS after ART and analyze the trend.

  3. The incidence of adverse reactions after ART. [ Time Frame: 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.


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.

Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HIV/AIDS who are willing to receive antiretroviral therapy.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667026


Contacts
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Contact: Linghua Li, MD,PhD llheliza@126.com

Locations
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China, Guangdong
Guangzhou Eighth People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua Li, MD, PhD         
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Investigators
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Principal Investigator: Ling-Hua Li, doctor Guangzhou Eighth People's Hospital
More Information
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Responsible Party: Linghua LI, Vice chief of Infectious Disease Center, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT04667026    
Other Study ID Numbers: GZ8HART-v1, 20200910
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:
HIV/AIDS
ART
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases