Switching From Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function (SPARE)

NCT01294761 NA COMPLETED

The main objective of this clinical trial in randomizing HIV infected patients under good HIV control with tenofovir (TDF), emtricitabine (or lamivudine) plus lopinavir/ritonavir (LPV/r) into switching the regimen to raltegravir (RAL) with darunavir/ritonavir (DRV/r) or continuing the ongoing regimen to compare these two groups' estimated glomerular filtration rate (eGFR) is to investigate whether anti-HIV treatment that does not contain TDF or other reverse-transcriptase inhibitors (NTRI sparing regimen) can be protective of patients' renal functions and has the same virological efficacy in comparison with a standard treatment with TDF, or not.

Details

Lead sponsor	National Center for Global Health and Medicine, Japan
Phase	NA
Status	COMPLETED
Enrolment	59
Start date	2011-02
Completion	2013-12

Conditions

• HIV Infections

Interventions

• Raltegravir, Darunavir/r

Primary outcomes

• eGFR improvement comparison of two arms by ITT analysis — 48 weeks
  To investigate whether the estimated glomerular filtration rate (eGFR) of the intervened group with RAL+DRV/r improves by 10% or more by intention to treat (ITT) analysis at the time of 48 weeks after the start of the study, or not.

Countries

Japan