Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study

David Garcia Cinca1 site in 1 country15 target enrollmentApril 2016

ConditionsHIV Infections

InterventionsAntiretroviral Therapy (Experimental)

DrugsAntiretroviral Therapy (Experimental)

Overview

Phase: Phase 3
Intervention: Antiretroviral Therapy (Experimental)
Conditions: HIV Infections
Sponsor: David Garcia Cinca
Enrollment: 15
Locations: 1
Primary Endpoint: Functional cure (Proportion of patients with undetectable viral reservoir)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

November 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

David Garcia Cinca

Responsible Party

Sponsor Investigator

Principal Investigator

David Garcia Cinca

Clinical Research Manager

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

•Men who have sex with men
•Male's between18 and 65 years old
•Less than 100 days of infection
•Patient stage Fiebig I to V
•Negative or Incomplete western blot with negative p31 band

Exclusion Criteria

•P31 positive band in western blot
•Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)
•Active oncological disease
•Active hepatitis C virus infection

Arms & Interventions

Antiretroviral treatment

Intervention: Antiretroviral Therapy (Experimental)

Outcomes

Primary Outcomes

Functional cure (Proportion of patients with undetectable viral reservoir)

Time Frame: 12 months of treatment

Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.

Secondary Outcomes

Proportion of patients with undetectable plasmatic HIV viral load(1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.)
Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)