Conditions: HIV Infections Proteinuria
Keywords: HIV Human immunodeficiency virus tenofovir viread truvada proteinuria
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated.

Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure

Detailed description:
As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir

Arms:
arm 1: Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Interventions: intervention 1: change from tenofovir to raltegravir
Intervention descriptions: intervention 1: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID

Protocol document: