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Intermittent ART in Primary HIV Infection (PHI-IL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02300623
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date November 25, 2014
Study Start Date  ICMJE March 2000
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Control of viral replication without ART. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Time to resume ART. [ Time Frame: 9 years after final 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 Intermittent ART in Primary HIV Infection
Official Title  ICMJE Long Term Follow-up of Patients Experiencing Structured Treatment Interruption (STI) With or Without Low Doses of Interleukin-2 During Primary HIV Infection (PHI)
Brief Summary Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.
Detailed Description The study design included two phases. The first phase consisted in four STI of 8 weeks each (off-ART), separated by 16 weeks of treatment -or the time necessary to reach again to PVL <20 copies/mL- (on-ART). At the end of the 4th off-ART cycle (week 0) an interim evaluation was performed and the second phase initiated. During the second phase, the first 6 patients received ART until they reach PVL<20 copies/mL, discontinuing thereafter (final stop). The last 6 patients received ART and low doses of IL-2. ARV therapy was stopped after reaching PVL<20 copies/mL (final stop) and IL-2 after 6 months of treatment. IL-2 was prescribed at a dose of 750.000 UI/m2 daily and was self-administrated in all patients previous trained by a specialized nurse. ART was resumed in patient dropping CD4 cell count less than 350 cell/mm3 in two consecutive determinations or in patients who developed opportunistic infections. A long term follow up analysis was performed at 3, 6 and 9 years since the final stop. It included time to resume ART, clinical events, survival rate, CD4-CD8-CD4/CD8 ratio.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: Antiretroviral therapy plus Interleukin-2
    Daily s.c. IL-2: 750,000 UI/m2/day for 6 months
    Other Names:
    • IL-2
    • Stavudine
    • Lamivudine
    • Indinavir
  • Drug: Antiretroviral therapy alone
    Standard antiretroviral therapy
    Other Names:
    • stavudine
    • Lamivudine
    • Indinavir
Study Arms  ICMJE
  • Active Comparator: Control
    Antiretroviral therapy alone
    Intervention: Drug: Antiretroviral therapy alone
  • Experimental: Treatment
    Antiretroviral therapy plus Interleukin-2'
    Intervention: Drug: Antiretroviral therapy plus Interleukin-2
Publications * Sued O, Ambrosioni J, Nicolás D, Manzardo C, Agüero F, Claramonte X, Plana M, Tuset M, Pumarola T, Gallart T, Gatell JM, Miró JM. Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes. PLoS One. 2015 Jul 17;10(7):e0131651. doi: 10.1371/journal.pone.0131651. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2014)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • PHI defined by detectable plasma viral load (PVL) or p24 antigen detection coupled with a negative or indeterminate LIA assay (according CDC criteria); negative HIV-1 EIA in the preceding 90 days or by a positive EIA and LIA assay with acute retroviral syndrome in the preceding 90 days of starting ART plus documented negative HIV-1 EIA within the previous year.
  • ART started within 90 days from the HIV exposure and continuing in the same treatment at least 12 months before the inclusion, and they must have shown good virological and immunological responses, defined as undetectable PVL (<20 copies/mL in the last two controls) and CD4 more than 500 cells/mm3 with a CD4/CD8 ratio >1 in the last 8 months previous to enrolment

Exclusion Criteria:

  • Infection of more than 90 days.
  • Age under 18 years old.
  • AIDS defining condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02300623
Other Study ID Numbers  ICMJE PHI-IL2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan A. Arnaiz, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Juan A. Arnaiz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josep Maria Miró, MDPhD Hospital Clinic of Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date November 2014

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