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

HIV Infections Clinical Trial

— VIRECURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02588820
• Other study ID #: 2015-000251-24
• Status: Recruiting
• Phase: Phase 3
• First received: October 20, 2015
• Last updated: August 16, 2016
• Start date: April 2016
• Est. completion date: November 2018

Study information

• Verified date: August 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Drug and Medical Device Spanish Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• Antiretroviral Therapy (Experimental)
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

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
David Garcia Cinca	Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No