Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

To investigate the potential for drug interactions between simeprevir and dolutegravir,
participants will receive each drug alone and the drugs in combination for 7 days. The
pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be
compared.

Inclusion Criteria:

- Men and women ages 18-60 years

- Absence of HIV-1 and HCV antibodies at screening,

- Ability and willingness to give written informed consent before the first
trial-related activity.

Exclusion Criteria:

- Pregnancy

- Breastfeeding

- Active alcohol or drug abuse that, in the opinion of the investigators, would
interfere with adherence to study requirements

- Participation in any investigational drug study within 30 days prior to study entry

- Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric,
metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or
malignancy requiring pharmacologic treatment, and/or if in the opinion of the
investigator, would affect study participation, safety, or integrity of results

- Use of concomitant medication, including investigational, prescription, and
over-the-counter products and dietary supplements with the following exceptions:
aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives

- Concomitant medications other than those listed above must have been discontinued at
least 14 days before study entry

- Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis,

- History of significant drug allergy (i.e., anaphylaxis and/or angioedema)

- Subjects with the following laboratory abnormalities at screening as defined by the
2004 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse
Events ("DAIDS grading table") and in accordance with the normal ranges of the trial
clinical laboratory: serum creatinine grade 1 or greater (≥ 1.1 x upper limit of
laboratory normal range (ULN)); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet
count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or
greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x
ULN), any other laboratory abnormality of grade 2 or above.