Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

Inclusion Criteria

• Documentation of Acute HIV infection at or within 30 days of study entry.
• Men and women age ≥18 years.
• ART naive, defined as ≤14 days of antiretroviral treatment at any time prior to entry. The only exceptions are:
• Pre-exposure prophylaxis (PrEP) and documented as HIV-1 negative at least 1 month prior to AHI diagnosis during PrEP, and
• Post-exposure prophylaxis (PEP) provided the participant was documented as HIV-1 negative at least 3-6 months following completion of PEP treatment.
• Lab values obtained within 30 days prior to study entry:
• Absolute neutrophil count >500/mm^3
• Hemoglobin > 8.5 g/dL for men and > 8.0 g/dL for women
• Platelet count >50,000/mm^3
• Lipase ≤ 3 X upper limit of normal (ULN), single repeat test is allowed to determine eligibility
• Calculated creatinine clearance (CrCl, Cockcroft-Gault formula) ≥ 50 mL/min:

CrCl = (140-age) x body weight (kg) (x 0.85 if female) Serum creatinine [mg/dL] x (72)

• Testing for HBsAg is pending. Note: Participants who test positive for HBsAg will be terminated from the study prior to starting study treatment.
• Testing for HLA-B57 and/or HLA-B*5701 is pending. Note: Participants who test positive for HLA-B*5701 will be terminated from the study prior to starting study treatment.
• A female is eligible to enter and participate in the study if she:
• Is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy; or,
• Is of child-bearing potential, with a negative pregnancy test at screening and at enrollment, who agrees to use one of the methods of contraception listed below.
• Complete abstinence from intercourse from 2 weeks prior to administration of study medication, throughout the study, and for at least 2 weeks after discontinuation of all study medication;
• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
• Approved hormonal contraception - used alone is not considered a sufficient form of contraception for the study see Protocol Appendix 1 for a listing of examples of approved hormonal contraception;
• Any intrauterine device (IUD) with published data showing that the expected failure rate is 35% direct bilirubin)
• Weight <40 kg
• Women who are breast-feeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Women and men of child bearing potential unwilling to agree to use an effective methods of contraception required by the study.
• History or presence of allergy to the study drugs or their components.
• Requires or is anticipated to require any of the prohibited concomitant therapy: barbiturates, dofetilide, fampridine (dalfampridine), modafinil, oxcarbazepine, pioglitazone, pilsicainide, pimozide, rifampin, rifapentine, phenytoin, phenobarbital, carbamazepine, and St. John's wort.
• Dofetilide, fampridine, and pilsicainide are prohibited, as DTG may inhibit its renal tubular secretion resulting in increased dofetilide concentrations and potential for toxicity.
• Unable to discontinue any current medications that are excluded during study treatment.
• Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), radiation therapy, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
• Prednisone at a daily dose of 10 mg or less (physiologic replacement dose) is permitted.
• Treatment with radiation therapy or cytotoxic chemotherapeutics agents within 28 days prior to screening or has an anticipated need for these agents during the study.
• Administration of an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
• Prior treatment with any other experimental drug for any indication (within 30 days of initiating study treatment).
• Difficulty swallowing