Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

Korábbi kezelés

• 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

Más betegség

• 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

Laborértékek

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

Egyéb

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

• 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.