Clinical Trials

MainTitle

Intermittent ART in Primary HIV Infection (PHI-IL2)

This study has been completed
Sponsor
Juan A. Arnaiz


Information provided by (Responsible Party)
Juan A. Arnaiz, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier
NCT02300623

First received: November 18, 2014
Last updated: November 21, 2014
Last Verified: November 2014
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV

Drug : Antiretroviral therapy plus Interleukin-2
Drug : Antiretroviral therapy alone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Follow-up of Patients Experiencing Structured Treatment Interruption (STI) With or Without Low Doses of Interleukin-2 During Primary HIV Infection (PHI)

Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures

  • Control of viral replication without ART. [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • Time to resume ART. [ Time Frame: 9 years after final stop ]

Enrollment: 12
Study Start Date: March 2000
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Control
Antiretroviral therapy alone
Drug: Antiretroviral therapy alone

Standard antiretroviral therapy

Other Name:
  • stavudine
  • Lamivudine
  • Indinavir

Experimental: Treatment
Antiretroviral therapy plus Interleukin-2'
Drug: Antiretroviral therapy plus Interleukin-2

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

Other Name:
  • IL-2
  • Stavudine
  • Lamivudine
  • Indinavir

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

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: NCT02300623

Locations

Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036

Sponsors and Collaborators

Juan A. Arnaiz

Investigators

Principal Investigator: Josep Maria Miró, MDPhD Hospital Clinic of Barcelona
More Information

More Information


Responsible Party: Juan A. Arnaiz, MD, Hospital Clinic of Barcelona  
ClinicalTrials.gov Identifier: NCT02300623   History of Changes  
Other Study ID Numbers: PHI-IL2  
Study First Received: November 18, 2014  
Last Updated: November 21, 2014  

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lamivudine
Stavudine
Indinavir
Interleukin-2

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.