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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Francisco General Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.