HIV II Infection Clinical Trial
Official title:
A Phase II, Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of Triple Therapy With Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects
Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs backbone in HIV-2 positive, treatment-naïve subjects.
Subjects who fulfill all inclusion criteria and none of the exclusion criteria, after giving
informed consent, will be eligible for participation in this study. At the Visit 2 (Day1)
subjects will receive the study medication and instructions for its administration.
Thereafter, subjects will return to the investigational site at week 4, 12, 24, 36 and 48,
for efficacy and safety assessments.
Subjects who meet the virologic failure criteria will return to the investigational site
approximately one week later to repeat viral RNA testing (Virologic Failure Confirmation
visit). If virologic failure is confirmed and the viral load meets the criteria for
resistance testing, viral resistance testing will then be performed.
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