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Functional Cure Study of HIV-infected Patients

12. marts 2018 opdateret af: Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung Medical University Chung-Ho Memorial Hospital Tropical Medicine Center

Although combination antiretroviral therapy (cART) can significantly reduce morbidity and mortality, it still fails to eradicate HIV. Given the difficulty for eradication of HIV, functional cure is more likely to achieve the goal. In recent breakthrough scientific reports, there already existed several examples of HIV-infected cases achieving the status of functional cure only through early administration of cART in newborns or early infected cases. From Taiwan centers for disease control (CDC) reports and our clinical experiences, more and more young men got HIV infection and the most important finding is the investigators can find some of them are newly infected, let's say, within six months.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Kaohsiung, Taiwan, 810
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 35 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. HIV
  2. Age over 20 years old to 35 years old.

Exclusion Criteria:

  1. Refuse to accept cases HAART
  2. Interruption of HAART cases during treatment.
  3. Can not rule taking HAART drugs, leading to treatment failure cases.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Recent infection patient
The patient who infected with HIV-1 and screened out by P24 ELISA, and they would receives early cART course.
Procedure: cART course
The investigators would start regular cART course immediately for early infection patients to achieve functional cure.
Andre navne:
  • HAART

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
In ELISA format test cases contain the plasma p24 Ag
Tidsramme: 3 to 5 years
Test cases contain the plasma p24 antigen and Detuned assay for early to tell whether a dye.
3 to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Monitoring of functional cure
Tidsramme: every six months till at least two years
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.
every six months till at least two years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Efterforskere

  • Ledende efterforsker: Jih-Jin Tsai, PhD, Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

23. maj 2017

Studieafslutning (Faktiske)

23. maj 2017

Datoer for studieregistrering

Først indsendt

26. marts 2016

Først indsendt, der opfyldte QC-kriterier

5. juni 2016

Først opslået (Skøn)

9. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2018

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • KMUHIRB-20140058

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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