drugset / Trial / NCT02300623

Intermittent ART in Primary HIV Infection

NCT02300623

Phase 4 Completed 12 enrolled Juan A. Arnaiz
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2000-03
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 750000 unknown Subcutaneous
Background INDINAVIR ANHYDROUS Other / unclassified
Background Lamivudine Other / unclassified
Background Stavudine Other / unclassified