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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Antiretroviral Therapy (Experimental)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiretroviral treatment<br> | Drug: Antiretroviral Therapy (Experimental)<br>* Initial ART until HLA-B5701 results became available (48 hours): Tenofovir 245 mg once a day Emtricitabine 200 mg once a day Dolutegravir 50 mg once a day Darunavir 800 mg once a day Ritonavir 100 mg once a day Maraviroc 150 mg twice a day Three months continuation treatment (after HLA-B5701 confirmed as negative): Dolutegravir 50 mg once a day. Abacavir 600 mg once a day Lamivudine 300 mg once a day Darunavir 800 mg once a day Ritonavir 100 mg once a day 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. Nine months continuation treatment (till complete 12 months treatment): Abacavir, 600mg once a day Lamivudine, 300 mg once a day Dolutegravir, 50 mg once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with undetectable plasmatic HIV viral load | In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months | 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 |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV