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

David Garcia Cinca15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Antiretroviral Therapy (Experimental)DRUG

1. Initial ART until HLA-B5701 results became available (48 hours): 1. Tenofovir 245 mg once a day 2. Emtricitabine 200 mg once a day 3. Dolutegravir 50 mg once a day 4. Darunavir 800 mg once a day 5. Ritonavir 100 mg once a day 6. Maraviroc 150 mg twice a day 2. Three months continuation treatment (after HLA-B5701 confirmed as negative): 1. Dolutegravir 50 mg once a day. 2. Abacavir 600 mg once a day 3. Lamivudine 300 mg once a day 4. Darunavir 800 mg once a day 5. Ritonavir 100 mg once a day 6. Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily. 3. Nine months continuation treatment (till complete 12 months treatment): 1. Abacavir, 600mg once a day 2. Lamivudine, 300 mg once a day 3. Dolutegravir, 50 mg once a day

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Functional cure (Proportion of patients with undetectable viral reservoir)

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.

Time frame: 12 months of treatment

Secondary Outcomes

Proportion of patients with undetectable plasmatic HIV viral load

In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months

Time frame: 1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.

Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

Time frame: 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

Time frame: 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

Time frame: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

Time frame: 1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

Data from ClinicalTrials.gov

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