Functional Cure Study of HIV-infected Patients
Condition: HIV
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): cART course
Intervention type(s): Procedure
Intervention description(s): The investigators would start regular cART course immediately for early infection patients to achieve functional cure.
Other intervention name(s): HAART
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic