Functional Cure Study of HIV-infected Patients
Kaohsiung Medical University Chung-Ho Memorial Hospital Tropical Medicine Center
Studie Overzicht
Gedetailleerde beschrijving
This study targets on this newly HIV- infected cohort and urging them to receive cART in order to achieve the possible status of HIV function cure. After 3~5 years period of treatment, cART will be discontinued after laboratory evaluation and functional cure is anticipated. These patients can achieve good life quality. In addition to elimination of the risk for HIV transmission, the cART expense of the government can be reduced on the large scale. The core of this study aims at setting up a precise and standard laboratory methodology for detecting the newly infected cases and predicting the time to stop cART. Once these assay methods are well established, they can be widely applied to assess the previous cases with long term cART for the prediction of the appropriate time to stop cART.
Thru the conventional HIV tests (within the sero-conversion stage), the detection rate of early infection is only 5-10 %. Therefore it is very desperately important to develop more tools for the diagnosis of early infection.
In addition to the standard method for detecting HIV infection, the investigators will use the HIV p24 Ag test and detuned Enzyme-linked Immunoblotting assay (EIA) assay for detecting early infection. For naïve patients, the investigators will also check the resistance testing for antiretroviral drugs in order to adjust and choose the susceptible cART for the patients. During the cART period, the investigators will follow up these patients for checking quantity of HIV RNA and proviral DNA (HIV DNA) from Peripheral blood mononuclear cell (PBMCs) in their blood. After three to five years of cART, if their HIV RNA is not detected and HIV DNA is very low, the investigators will draw the blood from the patients to isolate the Cluster of Differentiation 4 (CD4) receptors + T cells and co-cultivated with PBMCs from the healthy cohorts to evaluate the existence of HIV infectivity or not in the cART treated cases. If there is no infectivity, the investigators will stop cART. After stopping cART, the investigators will follow up these cases every six months till at least two years to check their HIV antibody, HIV RNA and HIV DNA from PBMCs to observe whether HIV recurrence occurs to them.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kaohsiung, Taiwan, 810
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- HIV
- Age over 20 years old to 35 years old.
Exclusion Criteria:
- Refuse to accept cases HAART
- Interruption of HAART cases during treatment.
- Can not rule taking HAART drugs, leading to treatment failure cases.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Recent infection patient
The patient who infected with HIV-1 and screened out by P24 ELISA, and they would receives early cART course.
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The investigators would start regular cART course immediately for early infection patients to achieve functional cure.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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In ELISA format test cases contain the plasma p24 Ag
Tijdsspanne: 3 to 5 years
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Test cases contain the plasma p24 antigen and Detuned assay for early to tell whether a dye.
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3 to 5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Monitoring of functional cure
Tijdsspanne: every six months till at least two years
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After three to five years of cART, if the subjects's HIV RNA is not detected and HIV DNA is very low, the investigators would draw the blood from the subjects to isolate the CD4 + T cells and co-cultivated with PBMCs from the healthy cohorts to evaluate the existence of HIV infectivity or not in the subjects.
If there is no infectivity, the investigators would stop subjects's cART course.After stopping cART, the investigators would follow up these subjects every six months till at least two years to check their HIV antibody, HIV RNA and HIV DNA from PBMCs to observe whether HIV recurrence occurs to them.
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every six months till at least two years
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jih-Jin Tsai, PhD, Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- KMUHIRB-20140058
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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