Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection

Phase 3

• Conditions: HIV Infections
• Interventions: Drug: Antiretroviral Therapy (Experimental)

• Registration Number: NCT02588820
• Lead Sponsor: David Garcia Cinca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Study Start: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antiretroviral treatment	Antiretroviral Therapy (Experimental)	-

Primary Outcome Measures

Name	Time	Method
Functional cure (Proportion of patients with undetectable viral reservoir)	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 Outcome Measures

Name	Time	Method
Proportion of patients with undetectable plasmatic HIV viral load	1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.	In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months
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

Trial Locations

Locations (1)

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain