HIV InfectionsRALPIRNCT01044771
Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria
A study testing change from tenofovir to raltegravir in people with HIV Infections and Proteinuria, run by Metropolis Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Proteinuria
- What is being tested?
- change from tenofovir to raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
Official title: A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads
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
Read the detailed description
As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir
- Conditions
- HIV Infections, Proteinuria
- Being tested
- change from tenofovir to raltegravir
- Keywords
- HIV, Human immunodeficiency virus, tenofovir, viread, truvada, proteinuria
- Medical subject headings
- HIV Infections, Proteinuria, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change from tenofovir to raltegravirDrug
Also called Isentress
Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
| Study group | Role | What they receive |
|---|---|---|
| change from tenofovir to raltegravir | Other | Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Receives: Drug: change from tenofovir to raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Reduced or Resolved Proteinuria
Measurement of Protein in Urine samples at end of study visit
Measured: 24 weeks
Secondary outcomes (1)
Patients Without HIV Re-bound
HIV Viral load blood test at week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metropolis Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Fritz Bredeek, MD, PhD, Metropolis Medical
- Investigators
- Fritz Bredeek, MD, Principal investigator, Metropolis Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044771
- Sponsor's protocol ID
- RALPIR
- Acronym
- RALPIR
- Status last verified
- May 2015
- First submitted
- 6 Jan 2010
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads
- ClinicalTrials.gov ID
- NCT01044771
- Acronym / sponsor ID
- RALPIR / RALPIR
- Conditions
- HIV Infections, Proteinuria
- Keywords
- HIV, Human immunodeficiency virus, tenofovir, viread, truvada, proteinuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Metropolis MedicalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| change from tenofovir to raltegravir | Other | Drug: change from tenofovir to raltegravirSingle arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change from tenofovir to raltegravirAlso: IsentressChange of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID | Drug | change from tenofovir to raltegravir |
Primary outcome
Patients With Reduced or Resolved Proteinuria
Time frame: 24 weeks
Measurement of Protein in Urine samples at end of study visit
1 secondary outcome
Patients Without HIV Re-bound
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fritz Bredeek, MD principal investigator
Metropolis Medical
Questions about this trial
What is this clinical trial studying?
A study testing change from tenofovir to raltegravir in people with HIV Infections and Proteinuria, run by Metropolis Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients With Reduced or Resolved Proteinuria (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.