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Intermittent ART in Primary HIV Infection

NCT02300623 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-11-25

No results posted yet for this study

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

Interventions

DRUG

Antiretroviral therapy plus Interleukin-2

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

DRUG

Antiretroviral therapy alone

Standard antiretroviral therapy

Sponsors & Collaborators

  • Juan A. Arnaiz

    lead OTHER

Principal Investigators

  • Josep Maria Miró, MDPhD · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300623 on ClinicalTrials.gov