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

David Garcia Cinca

Status and phase: Unknown; Phase 3

Conditions: HIV Infections

Treatments: Drug: Antiretroviral Therapy (Experimental)

Study type: Interventional

Funder types: Other

Identifiers

NCT02588820

2015-000251-24

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Antiretroviral treatment

Experimental group

Treatment:

Drug: Antiretroviral Therapy (Experimental)