The use of steroids in conjunction with antiretroviral therapy to treat HIV associated nephropathy to assist with treatment of renal functio

Not Applicable

Completed

• Conditions: HIV associated nephropathy; Urological and Genital Diseases; HIV-associated nephropathy (HIVAN)

• Registration Number: ISRCTN56112439
• Lead Sponsor: GROOTE SCHUUR HOSPITAL/ UNIVERSITY OF CAPE TOW

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30728003

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-18
• Study Start: 2018-09-05
• Last Update Posted: 13 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Histologically-proven HIV-associated nephropathy, defined as having the presence of chronic tubulointerstitial inflammation with plasma cells, lymphocytes and microcysts, along with any of the following:
1.1. Collapsing glomerulopathy
1.2. Focal segmental glomerulosclerosis
1.3. Podocyte hypertrophy and/or hyperplasia
2. Antiretroviral therapy naïve for at least 2 weeks prior to renal biopsy
3. Initiation of antiretroviral therapy within 1 month of the renal biopsy
3. Aged 18 years or older
4. Able to provide written informed consent

Exclusion Criteria

1. Any active infection
2. Kaposi sarcoma
3. Active cytomegalovirus
4. Inability to follow-up at study centre

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Improvement in the following renal outcomes in patients with glomerular or tubulointerstitial features of HIVAN as a result of corticosteroid therapy, from the at the baseline, then monthly for 6 months, then every 3 months for 2 years:<br> 1. Improvement in estimated glomerular filtration rate (eGFR), assessed using the CKD EPI formula<br> 2. Serum creatinine (mol/l), assessed using a blood test<br> 3. Urine protein/creatinine ratio (uPCR) (g/mmol), assessed using a blood test<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adverse events, assessed using death certificates, patient folders, records from HIV clinics and family members at every 3 months during the 2 year follow-up period<br> 2. Improvements in the following histologies, assessed using a renal biopsy at the baseline and after 6 months:<br> 2.1. Podocytopathy<br> 2.2. Interstitial fibrosis<br> 2.3. Lymphocytic cell infiltration<br> 2.4. Plasma cell infiltration<br>