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

Effects 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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21361

Enrollment

600

Registered

2014-05-28

Start date

2014-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal dysfunction

Interventions

Observational study including a non-interventional questionnaire

Eligibility

Inclusion criteria

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

Exclusion criteria: -Not on a TDF containing ART.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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 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 1 MRP4-i exposure, comorbidity, boosted protease inhibitor cART backbone).	—

Measure

Time frame

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 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 1 MRP4-i exposure, comorbidity, boosted protease inhibitor cART backbone).

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Contacts

Public ContactC. Rokx

Department of Internal Medicine Erasmus University Medical Centre Room D-418 PO Box 2040, 3000 CA, Rotterdam

c.rokx@erasmusmc.nl+316 813 363 28

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)