Trial Outcomes & Findings for Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria (NCT NCT01044771)

NCT ID: NCT01044771

Last Updated: 2015-05-12

Results Overview

Measurement of Protein in Urine samples at end of study visit

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2015-05-12

Participant Flow

Participant milestones

Measure	Change From Tenofovir to Raltegravir Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

Baseline characteristics by cohort

Measure	Change From Tenofovir to Raltegravir n=20 Participants Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Measurement of Protein in Urine samples at end of study visit

Outcome measures

Measure	Change From Tenofovir to Raltegravir n=20 Participants Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
Patients With Reduced or Resolved Proteinuria	20 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Subjects entered with undetectable Viral Load and Proteinuria

HIV Viral load blood test at week 24

Outcome measures

Measure	Change From Tenofovir to Raltegravir n=20 Participants Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
Patients Without HIV Re-bound	2 participants

Adverse Events

Change From Tenofovir to Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fritz Bredeek

Metropolis Medical

Phone: 415 292 5477

Email: fritz@doctor.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place