Functional Cure Study of HIV-infected Patients
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|ClinicalTrials.gov Identifier: NCT02794545|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Procedure: cART course||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kaohsiung Medical University Chung-Ho Memorial Hospital Tropical Medicine Center|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 23, 2017|
|Actual Study Completion Date :||May 23, 2017|
Experimental: 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.
Other Name: HAART
- In ELISA format test cases contain the plasma p24 Ag [ Time Frame: 3 to 5 years ]Test cases contain the plasma p24 antigen and Detuned assay for early to tell whether a dye.
- Monitoring of functional cure [ Time Frame: 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.
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): NCT02794545
|Kaohsiung medical University Chung-Ho Memorial Hospital|
|Kaohsiung, Taiwan, 810|
|Principal Investigator:||Jih-Jin Tsai, PhD||Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)|