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Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

NCT02656511 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-06-15

No results posted yet for this study

Summary

The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with very early HIV infection (estimated date of infection within the last 90 days). The primary aim of the study is to evaluate whether initiation of dolutegravir plus emtricitabine/tenofovir during acute/early HIV infection leads to protection of CD4+ T cells and other immune cells in the peripheral blood and lymphoid tissue from infection.

Conditions

Interventions

DRUG

Dolutegravir

Dolutegravir 50 mg PO daily

DRUG

Emtricitabine/Tenofovir

Emtricitabine 200 mg/Tenofovir alafenamide 25 mg PO daily

Sponsors & Collaborators

Principal Investigators

  • Sulggi Lee, MD PhD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2027-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02656511 on ClinicalTrials.gov