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NCT02656511Active, not recruitingPhase 4

Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

Immediate Initiation of Antiretroviral Therapy During Acute HIV Infection

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
74 (estimated)
First submitted
31 Dec 2015
Start date
Dec 2015
Primary completion date
May 2027
Lead sponsor
University of California, San Francisco
Diseases
HIV
NCT number
NCT02656511

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 74
  • From Dec 2015 to the primary completion date, May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent treatment with dofetilide, oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John's wort, or metformin
  • Serious illness requiring systemic treatment and/or hospitalization in the preceding 90 days prior to study enrollment
  • Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drugs in the preceding 90 days prior to study enrollment (e.g. IL-2, interferon-alpha, methotrexate, cancer chemotherapy)
  • Concurrent treatment with investigational drugs, or exposure to any investigational drugs in the preceding 90 days prior to study enrollment
  • Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements
  • Use of aspirin, NSAIDs, Plavix, Coumadin, or other blood thinners that cannot be stopped for clinical reasons for 5 days before and after each colorectal biopsy

Other illness

  • Known severe kidney disease (CrCl \< 60 ml/min via Cockcroft-Gault method)
  • Known severe hepatic impairment (Child-Pugh Class C)
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Participants with anticipated need for Hepatitis C virus (HCV) therapy during study
  • Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
  • Known blood coagulation disorder
  • Inflammatory colitis (e.g., Crohn's disease and/or ulcerative colitis) and/or any contraindications to sigmoidoscopy or colorectal biopsy such as peritonitis, active diverticulitis, or recent bowel surgery

Lab values

  • Platelets \< 50,000/mm\^3
  • PTT \> 2x upper limit of normal
  • INR \> 1.3

Other

  • Pregnant or breastfeeding women.
  • For participants who agree to colorectal biopsy

Who the study is looking for

  • Willing and able to provide written informed consent
  • Male or female, age ≥18 years
  • Acute HIV infection with a negative or indeterminate HIV-1 antibody test and plasma HIV-1 RNA \> 40 cp/ml, OR clinical history consistent with new HIV infection in the last 90 days.
  • Antiretroviral therapy untreated or recently initiated (within 7 days)
  • Participant must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
  • All participants must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization)..
  • When participating in sexual activity that could lead to pregnancy, female participants must agree to use a double barrier method of contraception for at least two weeks after discontinuation of study drug.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
San Francisco General Hospital
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.