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

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ClinicalTrials.gov Identifier: NCT02588820
Recruitment Status : Unknown
Verified August 2016 by David Garcia Cinca, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : October 28, 2015
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Fundacion Clinic per a la Recerca Biomédica
Information provided by (Responsible Party):
David Garcia Cinca, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date August 17, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection
Official Title  ICMJE Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Antiretroviral treatment
Intervention: Drug: Antiretroviral Therapy (Experimental)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 26, 2015)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02588820
Other Study ID Numbers  ICMJE 2015-000251-24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Garcia Cinca, Hospital Clinic of Barcelona
Study Sponsor  ICMJE David Garcia Cinca
Collaborators  ICMJE Fundacion Clinic per a la Recerca Biomédica
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP