NCT02794545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2017

Completed
Last Updated

March 13, 2018

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

March 26, 2016

Last Update Submit

March 12, 2018

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • In ELISA format test cases contain the plasma p24 Ag

    Test cases contain the plasma p24 antigen and Detuned assay for early to tell whether a dye.

    3 to 5 years

Secondary Outcomes (1)

  • Monitoring of functional cure

    every six months till at least two years

Study Arms (1)

Recent infection patient

EXPERIMENTAL

The patient who infected with HIV-1 and screened out by P24 ELISA, and they would receives early cART course.

Procedure: cART course

Interventions

cART coursePROCEDURE

The investigators would start regular cART course immediately for early infection patients to achieve functional cure.

Also known as: HAART
Recent infection patient

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV
  • Age over 20 years old to 35 years old.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung medical University Chung-Ho Memorial Hospital

Kaohsiung City, 810, Taiwan

Location

MeSH Terms

Interventions

Antiretroviral Therapy, Highly Active

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Jih-Jin Tsai, PhD

    Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2016

First Posted

June 9, 2016

Study Start

October 1, 2014

Primary Completion

May 23, 2017

Study Completion

May 23, 2017

Last Updated

March 13, 2018

Record last verified: 2016-09

Locations

TW(1)