Impact of extremely early antiretroviral therapy to reduce VIral REservoir and induce functional CURE of HIV-1 infection. A pilot comparative study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000251-24-ES

Enrollment

Registered

2015-06-15

Start date

2015-06-10

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection

Interventions

Trade Name: VIREAD 245 mg COMPRIMIDOS CON CUBIERTA PELICULAR Product Name: Tenofovir Pharmaceutical Form: Coated tablet Trade Name: EMTRIVA 200 mg cáps

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: a. MSM (Men who have sex with men) b. Male?s between18 and 65 years old c. Less than 100 days of infection d. Patient stage Fiebig I to V e. Negative or Incomplete WB with negative p31 band Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. P31 positive band in WB b. Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late? exclusion criteria) c. Active oncological disease d. Active HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: To study whether it is possible to induce a state of functional cure after 12 months of aggressive ART in patients with very/extremely early treatment after PHI.; Secondary Objective: 1. To analyze the impact of extremely early ART to reduce VR and normalize bacterial translocation, immune activation and inflammation in patients with Fiebig stage I-II infection (less than 20 days post-infection). 2. To compare the level of reduction of VR, bacterial translocation, immune activation and inflammation among patients treated in phase I-II Fiebig (HIV infection less than 20 days) and patients treated in Fiebig stage III-V (20-100 days post-infection). ;Primary end point(s): Proportion of patients in both groups with undetectable VR in peripheral and rectal tissue CD4+ T cells at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation; Timepoint(s) of evaluation of this end point: VR in peripheral and rectal tissue CD4+ T cells at 1, 3 and 12 months after ART initiation. VR in rectal tissue at one year post-ART initiation.	—

Measure

Time frame

Main Objective: To study whether it is possible to induce a state of functional cure after 12 months of aggressive ART in patients with very/extremely early treatment after PHI.; Secondary Objective: 1. To analyze the impact of extremely early ART to reduce VR and normalize bacterial translocation, immune activation and inflammation in patients with Fiebig stage I-II infection (less than 20 days post-infection). 2. To compare the level of reduction of VR, bacterial translocation, immune activation and inflammation among patients treated in phase I-II Fiebig (HIV infection less than 20 days) and patients treated in Fiebig stage III-V (20-100 days post-infection). ;Primary end point(s): Proportion of patients in both groups with undetectable VR in peripheral and rectal tissue CD4+ T cells at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation; Timepoint(s) of evaluation of this end point: VR in peripheral and rectal tissue CD4+ T cells at 1, 3 and 12 months after ART initiation. VR in rectal tissue at one year post-ART initiation.

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Secondary

Measure	Time frame
Secondary end point(s): 1. In those patients with undetectable viral reservoir stopping ART at 12 months, the proportion of patients with undetectable plasmatic HIV viral load at 1, 3 and 12 months post-stop will be evaluated. 2. Viral reservoir, immune activation, inflammation, bacterial translocation and coagulation at 1, 3, 12 months will be measured in patients on ART. The same parameters will be evaluated in the patients with undetectable viral reservoir stopping ART at 12 months at 1, 3, 12 months post-stop. ; Timepoint(s) of evaluation of this end point: 1. In those patients with undetectable viral reservoir stopping ART at 12 months, the proportion of patients with undetectable plasmatic HIV viral load at 1, 3 and 12 months post-stop will be evaluated. 2. Viral reservoir, immune activation, inflammation, bacterial translocation and coagulation at 1, 3, 12 months will be measured in patients on ART. The same parameters will be evaluated in the patients with undetectable viral reservoir stopping ART at 12 months at 1, 3, 12 months post-stop.	—

Measure

Time frame

Secondary end point(s): 1. In those patients with undetectable viral reservoir stopping ART at 12 months, the proportion of patients with undetectable plasmatic HIV viral load at 1, 3 and 12 months post-stop will be evaluated. 2. Viral reservoir, immune activation, inflammation, bacterial translocation and coagulation at 1, 3, 12 months will be measured in patients on ART. The same parameters will be evaluated in the patients with undetectable viral reservoir stopping ART at 12 months at 1, 3, 12 months post-stop. ; Timepoint(s) of evaluation of this end point: 1. In those patients with undetectable viral reservoir stopping ART at 12 months, the proportion of patients with undetectable plasmatic HIV viral load at 1, 3 and 12 months post-stop will be evaluated. 2. Viral reservoir, immune activation, inflammation, bacterial translocation and coagulation at 1, 3, 12 months will be measured in patients on ART. The same parameters will be evaluated in the patients with undetectable viral reservoir stopping ART at 12 months at 1, 3, 12 months post-stop.

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Countries

Spain

Contacts

Public ContactJaime Camacho

CTU Clinic (Clinical Trials Unit)

jcamacho@clinic.ub.es349322754004386

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026