search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


De invloed van gelijktijdig gebruik van NSAIDs en andere MRP-4 remmers op de nieren bij HIV patiŽnten die worden behandeld met TDF bevattend antiretroviraal regiems. De NSHIV studie.


- candidate number17979
- NTR NumberNTR4618
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2014
- Secondary IDsMEC-2014-132. 
- Public TitleDe invloed van gelijktijdig gebruik van NSAIDs en andere MRP-4 remmers op de nieren bij HIV patiŽnten die worden behandeld met TDF bevattend antiretroviraal regiems. De NSHIV studie.
- Scientific TitleEffects of the concomitant use of non-steroidal anti-inflammatory drugs and other inhibitors of the tubular multidrug resistance protein 4 transporter on the renal function of HIV-1 infected patients treated with tenofovir disoproxil fumarate containing antiretroviral regimens.
- ACRONYMThe NSHIV study.
- hypothesisThe mean 12 months eGFR change between adult HIV-1 patients on TDF containing cART without reported NSAID/MRP4-i exposure will be greater than HIV-1 patients on TDF containing cART in the highest quartile of monthly cumulative DDD NSAID exposure (or other MRP4 inhibitors).
- Healt Condition(s) or Problem(s) studiedKidney fuction, HIV-positive patients
- Inclusion criteria- >18 years of age.
- HIV-1 positive.
- On TDF containing cART.
- Ability to understand and sign informed consent form prior to the initiation of any study procedures.
- Exclusion criteria-Not on a TDF containing ART.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-okt-2014
- Target number of participants600
- InterventionsObservational study including a non-interventional questionnaire
- Primary outcomeThe following parameter will be assessed in HIV-1 patients on TDF containing cART for at least 12 months. Monthly cumulative defined daily dose (DDD) will be calculated by using WHO definitions (22).

1. The difference in mean 12 months eGFR change between adult HIV-1 patients on TDF containing cART without reported NSAID/MRP4-i exposure and monthly cumulative DDD NSAID exposure (or other MRP4 inhibitors) per quartile.
- Secondary outcomeThe following parameter will be assessed in all HIV-1 patients on TDF containing cART.

1. The frequency of NSAID/other MRP4-i exposure will be assessed by ratio of the total number of HIV-1 patients on TDF containing cART that report NSAID/other MRP4-i exposure during the previous 6 months and to the total number of HIV-1 infected patients on TDF containing cART.

The following parameter will be assessed in HIV-1 patients on TDF containing cART for at least 12 months.

2. The correlation between the monthly cumulative DDD NSAID/other MRP4-i exposure on the eGFR course during the last 12 months.

3. The proportion of patients with eGFR MDRD decline of >5mL/min, >10mL/min and >20mL/min over a 12 month period in adult HIV-1 patients on TDF containing cART without NSAID/other MRP4-I exposure and per quartile monthly cumulative DDD NSAID/other MRP4-i exposure.

4. The relation between no NSAID/other MPR4-i exposure and NSAID/other MRP4-i monthly cumulative DDD exposure per quartile and fractional phosphate excretion (FePO4-) >20% or <20% for normal serum phosphate and >5% in cases of serum hypophosphatemia.

5. The relation between no NSAID/other MPR4-i exposure and NSAID/other MRP4-i monthly cumulative DDD exposure per quartile and normoglycemic glucosuria (present/absent).

6. The relation between no NSAID/other MPR4-i exposure and NSAID/other MRP4-i monthly cumulative DDD exposure per quartile and uAPR °‹0.4 or uAPR >0.4.

7. To evaluate the additional influence of no NSAID/other MPR4-i exposure and NSAID/other MRP4-i monthly cumulative DDD exposure per quartile on eGFR decline, uAPR (°‹0.4 / >0.4), normoglycaemic glucosuria (absent/present) and FEPO4- (>20% and <20%) in HIV-1 patients on TDF in combination in the predefined subgroups (nephrotoxic medication, >1 MRP4-i exposure, comorbidity, boosted protease inhibitor cART backbone).
- TimepointsCrossectional
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES C. Rokx
- CONTACT for SCIENTIFIC QUERIES C. Rokx
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsNA
- Brief summaryNA
- Main changes (audit trail)
- RECORD28-mei-2014 - 10-jul-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl