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

August 16, 2016 updated by: David Garcia Cinca

Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial de Barcelona
        • Contact:
          • Josep Maria Miró, MD
          • Phone Number: +34 337 54 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiretroviral treatment
Drug: Antiretroviral Therapy (Experimental)

  1. Initial ART until HLA-B5701 results became available (48 hours):

    1. Tenofovir 245 mg once a day
    2. Emtricitabine 200 mg once a day
    3. Dolutegravir 50 mg once a day
    4. Darunavir 800 mg once a day
    5. Ritonavir 100 mg once a day
    6. Maraviroc 150 mg twice a day

  2. Three months continuation treatment (after HLA-B5701 confirmed as negative):

    1. Dolutegravir 50 mg once a day.
    2. Abacavir 600 mg once a day
    3. Lamivudine 300 mg once a day
    4. Darunavir 800 mg once a day
    5. Ritonavir 100 mg once a day
    6. 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.

  3. Nine months continuation treatment (till complete 12 months treatment):

    1. Abacavir, 600mg once a day
    2. Lamivudine, 300 mg once a day
    3. Dolutegravir, 50 mg once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional cure (Proportion of patients with undetectable viral reservoir)
Time Frame: 12 months of treatment
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.
12 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with undetectable plasmatic HIV viral load
Time Frame: 1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.
In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months
1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.
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
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
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
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
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
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop
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
1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Garcia Cinca

Collaborators

Fundacion Clinic per a la Recerca Biomédica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-000251-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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