Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Single-arm Study of the Safety, Efficacy and Central Nervous System and Plasma PK of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily in Combination With the Abacavir/Lamivudine Fixed Dose Combination Tablet Over 96 Weeks in HIV-1 Infected Antiretroviral Naive Adult Subjects
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects who fulfill eligibility requirements will receive dolutegravir (DTG) 50 mg once daily in combination with the fixed dose dual nucleoside reverse transcripatase inhibitor(NRTI) abacavir/lamivudine (ABC/3TC) for 96 weeks. One pair of pharmacokinetic (PK) samples in plasma and cerebral spinal fluid (CSF) (matching time) for determination of DTG concentration will be collected at Week 2 and Week 16. Samples for plasma HIV-1 RNA will be collected at Baseline and various time points throughout the study and samples for HIV-1 RNA levels in the CSF will be collected at Baseline, Week 2 and Week 16. Safety, additional measures of antiviral activity and development of viral resistance will also be evlauated. The primary analysis will take place after the last subject completes 16 weeks on therapy; additional analyses will be conducted after the last subject completes Weeks 2 and 96 (end of study).
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be
conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.
Subjects who meet all screening requirements may enter the study and initiate treatment as
soon as all screening procedures have been completed and results are available and on file.
The 14-day screening period may be extended to 28 days to allow receipt of all Screening
assessment results and to accommodate scheduling.
Subjects who fulfill eligibility requirements will receive dolutegravir (DTG) 50 mg once
daily in combination with the fixed dose dual nucleoside reverse transcripatase
inhibitor(NRTI) abacavir/lamivudine ABC/3TC for 96 weeks. One pair of pharmacokinetic (PK)
samples in plasma and CSF (matching time) for determination of DTG concentration will be
collected at Week 2 and Week 16. Samples for plasma HIV-1 RNA will be collected at Baseline
and various time points throughout the study and samples for HIV-1 RNA levels in the CSF
will be collected at Baseline, Week 2 and Week 16. Safety, additional measures of antiviral
activity and development of viral resistance will also be evlauated. The primary analysis
will take place after the last subject completes 16 weeks on therapy; additional analyses
will be conducted after the last subject completes Weeks 2 and 96 (end of study).
Subjects are considered to have completed the study if they remain on therapy (i.e., have
not permanently discontinued investigational product [IP]) and complete the Treatment Phase,
including the Week 96 visit.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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