Try our beta test site

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hospital Clinic of Barcelona
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
David Garcia Cinca, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT02588820
First received: October 20, 2015
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
HIV Infections
Drug: Antiretroviral Therapy (Experimental)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 15
Study Start Date: April 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02588820

Locations
Spain
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Josep Maria Miró, MD    +34 337 54 00      
Sponsors and Collaborators
David Garcia Cinca
Fundacion Clinic per a la Recerca Biomédica
  More Information

Responsible Party: David Garcia Cinca, Clinical Research Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02588820     History of Changes
Other Study ID Numbers: 2015-000251-24
Study First Received: October 20, 2015
Last Updated: August 16, 2016

Keywords provided by Hospital Clinic of Barcelona:
HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on March 27, 2017