HIV Clinical Trial
Official title:
Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.
The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).
This is a randomized, controlled, open-label trial to investigate the antiviral activity,
tolerability and safety of TMC114/r) versus lpv/rtv in treatment-naive HIV-1 infected
patients. Six hundred sixty treatment-naïve HIV-1 infected patients will be randomized in a
1:1 ratio to either 800/100 mg of TMC114/r once daily, or a total daily dose of 800/200 mg
of lpv/rtv. All patients will take TMC114/r or lpv/rtv in combination with an NRTI
background of Truvada (a combination pill of tenofovir and emtricitabine, "TDF/FTC"). The
trial will consist of a screening period of approximately 14 to 28 days and a 96-week
treatment period, followed by a 4-week follow-up period. The anti HIV-1 therapy initiated at
baseline cannot be changed until the end of the treatment period. After the end of the
treatment period (maximum of 96 weeks), patients will be followed for an additional 4 weeks
to follow-up on any adverse events or laboratory abnormalities until resolution. Patients
who fail either virologically or due to intolerance from the TMC114/r or lpv/rtv therapy, as
judged by the investigator, or who meet one of the withdrawal criteria will be withdrawn
from the trial and may have the opportunity to participate in the rollover phase of the
trial.
The primary efficacy parameter is virologic response defined as a confirmed viral load < 50
copies/mL at Week 48 the objective of this study is to establish non-inferiority of TMC114/r
versus lpv/rtv in terms of virologic response at Week 48 using a non-inferiority margin of
12%. To test this hypothesis, a two-sided 95% confidence interval (CI) of the difference in
response rate between TMC114/r and lpv/rtv will be derived: If the lower bound of the CI
exceeds -12%, non-inferiority will be concluded. Patients will take oral doses for up to 96
weeks of either 800/100mg of TMC114/r 1x/day or 800/200mg of lpv/rtv once daily, each in
combination with TDF/FTC. (The 400/100 mg 2x/day dose of lpv/rtv will be used where the
1x/day use of lpv/rtv is not approved).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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