Intermittent ART in Primary HIV Infection

NCT02300623 | Completed Phase 4 DMC

• 1 other identifier: PHI-IL2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Control of viral replication without ART.

  48 weeks

Secondary Outcomes (1)

• Time to resume ART.

  9 years after final stop

Study Arms (2)

Control

ACTIVE COMPARATOR

Antiretroviral therapy alone

Drug: Antiretroviral therapy alone

Treatment

EXPERIMENTAL

Antiretroviral therapy plus Interleukin-2'

Drug: Antiretroviral therapy plus Interleukin-2

Interventions

Antiretroviral therapy plus Interleukin-2 DRUG

Daily s.c. IL-2: 750,000 UI/m2/day for 6 months

Also known as: IL-2, Stavudine, Lamivudine, Indinavir

Treatment

Antiretroviral therapy alone DRUG

Standard antiretroviral therapy

Also known as: stavudine, Lamivudine, Indinavir

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Infection of more than 90 days.
• Age under 18 years old.
• AIDS defining condition

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• Sued O, Ambrosioni J, Nicolas D, Manzardo C, Aguero F, Claramonte X, Plana M, Tuset M, Pumarola T, Gallart T, Gatell JM, Miro 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.

  PMID: 26186440 DERIVED

MeSH Terms

Interventions

Interleukin-2; Stavudine; Lamivudine; Indinavir

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyridines

Study Officials

• Josep Maria Miró, MDPhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 25, 2014
• Study Start: March 1, 2000
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

ES (1)