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Summary

for people ages 18 years and up
at San Francisco, California
study started
estimated completion:

Description

Summary

The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with "hyperacute" infection (estimated date of HIV infection within the last 30 days). The primary aim of the study is to evaluate whether initiation of dolutegravir plus emtricitabine/tenofovir during hyperacute HIV infection leads to protection of CD4+ T cells in the peripheral blood and gut-associated lymphoid tissue from infection.

Details

Although ART decreases HIV-associated mortality, it does not appear to completely restore immune health, for reasons that remain unclear. In addition, while HIV prevention approaches have led to significant successes in decreasing the incidence of new HIV infection over the past few years, the epidemic continues to grow both locally and globally. A synergistic strategy to HIV prevention is to effectively eradicate virus from HIV-infected persons. While complete eradication may not currently be feasible, a "functional cure" in which patients are able to indefinitely maintain undetectable viral loads in the absence of therapy may be an attainable immediate goal. Studying hyperacute HIV-infected individuals will provide a unique opportunity to investigate the pathophysiology of the earliest stages of HIV infection and may help identify the virologic/immunologic predictors of a functional cure.

Keywords

HIV immediate antiretroviral therapy hyperacute infection Tenofovir Emtricitabine Dolutegravir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Willing and able to provide written informed consent
  2. Male or female, age ≥18 years
  3. 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 30 days.
  4. Antiretroviral therapy untreated
  5. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
  6. All subjects must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization)..
  7. When participating in sexual activity that could lead to pregnancy, female subjects must agree to use a doublebarrier method of contraception for at least two weeks after discontinuation of study drug.

You CAN'T join if...

  1. Known severe kidney disease (CrCl < 60 ml/min via Cockcroft-Gault method)
  2. Known severe hepatic impairment (Child-Pugh Class C)
  3. 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)
  4. Subjects with anticipated need for Hepatitis C virus (HCV) therapy during study
  5. Concurrent treatment with dofetilide, oxcarbazepine, phenytoin, phenobarbital,carbamazepine, St. John's wort, or metformin
  6. Serious illness requiring systemic treatment and/or hospitalization in the preceding 90 days prior to study enrollment
  7. 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)
  8. Concurrent treatment with investigational drugs, or exposure to any investigational drugs in the preceding 90 days prior to study enrollment
  9. Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements
  10. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
  11. Pregnant or breastfeeding women.
  12. For subjects who agree to colorectal biopsy
  13. Known blood coagulation disorder
  14. Platelets < 50,000/mm^3
  15. PTT> 2x upper limit of normal
  16. INR> 1.3
  17. 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
  18. 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

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02656511
Phase
Phase 4
Lead Scientist
Sulggi Lee
Study Type
Interventional
Last Updated
September 12, 2016
I’m interested in this study!