N/A N=20 Treatment

Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

HIV Infections · Proteinuria

Bottom Line

View on ClinicalTrials.gov: NCT01044771 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Patients With Reduced or Resolved Proteinuria — 20 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: change from tenofovir to raltegravir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Metropolis Medical
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With Reduced or Resolved Proteinuria	20	—
SECONDARY Patients Without HIV Re-bound	2	—

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

Eligibility Criteria

Inclusion Criteria

Documented HIV infection
Ability to comply to protocol requirements
On stable HAART for minimum of 12 weeks
Evidence of TDF induced proteinuria
No evidence of prior Protease inhibitor failure
Treatment-naïve to integrase inhibitors
VL<200 x 12 weeks (minimum of 2 viral load measurements)

Exclusion Criteria

Active Hepatitis B infection
Proteinuria predating tenofovir use
PRAMs on historic GT or PT
Life expectancy less than 6 months
Subjects with any ongoing AIDS defining illness
Any condition which could compromise the safety of study subject
Grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01044771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.