A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects

NCT00830804 Phase 2 COMPLETED Results posted

The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

Details

Lead sponsor	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Phase	Phase 2
Status	COMPLETED
Enrolment	113
Start date	2009-04
Completion	2010-09

Conditions

• HIV-1 Infections

Interventions

• Raltegravir
• Darunavir/Ritonavir

Primary outcomes

• Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 — From start of study treatment to week 24
  Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \>= 1000 copies/ml or confirmed rebound from the week 4 value by \>0.5 log10 copies/ml (for subjects with week 4 value \<= 50 copies/ml, confirmed rebound to \>50 copies/ml); at week 24 or later, confirmed value \> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

Countries

United States