Trial Outcomes & Findings for HIV and Kidney Function Study (NCT NCT00905151)

Results Overview

Overall bias, median difference (95% confidence interval), mL/min per 1.73 m\^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.

Recruitment status

COMPLETED

Target enrollment

206 participants

Primary outcome timeframe

Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.

Results posted on

2017-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	HIV Positive A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
Overall Study STARTED	206
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV and Kidney Function Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV Positive n=200 Participants A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	194 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.

Overall bias, median difference (95% confidence interval), mL/min per 1.73 m\^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.

Outcome measures

Outcome measures
Measure	HIV Positive n=200 Participants Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
Performance of Glomerular Filtration Rate (GFR) Estimating Equations MDRD study	10.9 mL/min per 1.73 m^2 Interval 8.0 to 14.0
Performance of Glomerular Filtration Rate (GFR) Estimating Equations CKD-EPI creatinine	5.4 mL/min per 1.73 m^2 Interval 2.7 to 7.9
Performance of Glomerular Filtration Rate (GFR) Estimating Equations CKD-EPI cystatin C	4.3 mL/min per 1.73 m^2 Interval 1.2 to 7.7
Performance of Glomerular Filtration Rate (GFR) Estimating Equations CKD-EPI creatinin-cystatin	6.4 mL/min per 1.73 m^2 Interval 3.1 to 9.3

Adverse Events

HIV Positive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor

Tufts Medical Center

Phone: 617-636-2569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place