Conditions: HIV Hepatitis C
Keywords: dolutegravir simeprevir HIV HCV
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief summary:
The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.

Detailed description:
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.

Arms:
arm 1: Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir. arm 2: Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only. arm 3: Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir. arm 4: Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only. arm 5: Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only. arm 6: Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.

Interventions: intervention 1: dolutegravir intervention 2: simeprevir
Intervention descriptions: intervention 1: dolutegravir tablets 50mg, once daily x 7 days. intervention 2: simeprevir tablets 150mg, once daily x 7 days.

Protocol document: