HIV Infections, Proteinuria
Conditions
Keywords
HIV, Human immunodeficiency virus, tenofovir, viread, truvada, proteinuria
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
Interventions
DRUGchange from tenofovir to raltegravir
Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
Sponsors
Merck Sharp & Dohme LLC
Metropolis Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Reduced or Resolved Proteinuria | 24 weeks | Measurement of Protein in Urine samples at end of study visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Without HIV Re-bound | 24 weeks | HIV Viral load blood test at week 24 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Change From Tenofovir to Raltegravir Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Change From Tenofovir to Raltegravir |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Patients With Reduced or Resolved Proteinuria
Measurement of Protein in Urine samples at end of study visit
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Change From Tenofovir to Raltegravir | Patients With Reduced or Resolved Proteinuria | 20 participants |
Secondary
Patients Without HIV Re-bound
HIV Viral load blood test at week 24
Time frame: 24 weeks
Population: Subjects entered with undetectable Viral Load and Proteinuria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Change From Tenofovir to Raltegravir | Patients Without HIV Re-bound | 2 participants |