Observational Study on Patients With HIV/AIDS(OSPWH)

Study Overview
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Brief Summary
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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
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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. 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. To investigate the complications of HIV/AIDS patients before and after ART. To investigate the mortality and causes of death in patients with HIV/AIDS.

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

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| All-cause mortality among HIV/AIDS after ART. | Describe the all-cause mortality among HIV/AIDS after ART and analyze the trend. | Year 10 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, ART