Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

NCT01044771 | Completed Results DMC

• 1 other identifier: RALPIR
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infections; Proteinuria

Keywords

HIV; Human immunodeficiency virus; tenofovir; viread; truvada; proteinuria

Outcome Measures

Primary Outcomes (1)

• Patients With Reduced or Resolved Proteinuria

  Measurement of Protein in Urine samples at end of study visit

  24 weeks

Secondary Outcomes (1)

• Patients Without HIV Re-bound

  24 weeks

Study Arms (1)

change from tenofovir to raltegravir

OTHER

Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Drug: change from tenofovir to raltegravir

Interventions

change from tenofovir to raltegravir DRUG

Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID

Also known as: Isentress

change from tenofovir to raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Metropolis Medical: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

HIV Infections; Proteinuria; Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Fritz Bredeek
• Organization: Metropolis Medical

fritz@doctor.com

415 292 5477

Study Officials

• Fritz Bredeek, MD

  Metropolis Medical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-05