search
Back to results

Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection (VIRECURE)

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Antiretroviral Therapy (Experimental)
Sponsored by
David Garcia Cinca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men who have sex with men
  • Male's between18 and 65 years old
  • Less than 100 days of infection
  • Patient stage Fiebig I to V
  • Negative or Incomplete western blot with negative p31 band

Exclusion Criteria:

  • P31 positive band in western blot
  • Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)
  • Active oncological disease
  • Active hepatitis C virus infection

Sites / Locations

  • Hospital Clínic i Provincial de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antiretroviral treatment

Arm Description

Outcomes

Primary Outcome Measures

Functional cure (Proportion of patients with undetectable viral reservoir)
Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.

Secondary Outcome Measures

Proportion of patients with undetectable plasmatic HIV viral load
In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months
Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

Full Information

First Posted
October 20, 2015
Last Updated
August 16, 2016
Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica
search

1. Study Identification

Unique Protocol Identification Number
NCT02588820
Brief Title
Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection
Acronym
VIRECURE
Official Title
Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiretroviral treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Antiretroviral Therapy (Experimental)
Intervention Description
Initial ART until HLA-B5701 results became available (48 hours): Tenofovir 245 mg once a day Emtricitabine 200 mg once a day Dolutegravir 50 mg once a day Darunavir 800 mg once a day Ritonavir 100 mg once a day Maraviroc 150 mg twice a day Three months continuation treatment (after HLA-B5701 confirmed as negative): Dolutegravir 50 mg once a day. Abacavir 600 mg once a day Lamivudine 300 mg once a day Darunavir 800 mg once a day Ritonavir 100 mg once a day Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily. Nine months continuation treatment (till complete 12 months treatment): Abacavir, 600mg once a day Lamivudine, 300 mg once a day Dolutegravir, 50 mg once a day
Primary Outcome Measure Information:
Title
Functional cure (Proportion of patients with undetectable viral reservoir)
Description
Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.
Time Frame
12 months of treatment
Secondary Outcome Measure Information:
Title
Proportion of patients with undetectable plasmatic HIV viral load
Description
In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months
Time Frame
1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.
Title
Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time Frame
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Title
Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time Frame
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Title
Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time Frame
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
Title
Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V
Time Frame
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men who have sex with men Male's between18 and 65 years old Less than 100 days of infection Patient stage Fiebig I to V Negative or Incomplete western blot with negative p31 band Exclusion Criteria: P31 positive band in western blot Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria) Active oncological disease Active hepatitis C virus infection
Facility Information:
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Maria Miró, MD
Phone
+34 337 54 00

12. IPD Sharing Statement

Learn more about this trial

Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection

We'll reach out to this number within 24 hrs