No registrations found.
ID
Source
Brief title
Health condition
Renal dysfunction; proximal tubulopathy; HIV-1
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
The 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 ¡Ü0.4 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 (¡Ü0.4 / >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).
Background summary
NA
Study objective
The 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).
Study design
Crossectional
Intervention
Observational study including a non-interventional questionnaire
Erasmus University Medical Centre <br>
Room D-418 <br>
PO Box 2040, 3000 CA, Rotterdam
C. Rokx
Rotterdam
The Netherlands
+316 813 363 28
c.rokx@erasmusmc.nl
Erasmus University Medical Centre <br>
Room D-418 <br>
PO Box 2040, 3000 CA, Rotterdam
C. Rokx
Rotterdam
The Netherlands
+316 813 363 28
c.rokx@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4485 |
| NTR-old | NTR4618 |
| Other | : MEC-2014-132. |