IDV Associated Nephrotoxicity
Conditions
Keywords
IDV nephrotoxicity
Brief summary
Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.
Detailed description
Primary objective: To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction. Secondary objective: 1. To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48 2. To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48 3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48 4. To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects
Interventions
DRUGSaquinavir
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
Sponsors
Roche Pharma AG
Ministry of Health, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* IDV containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations * Viral load less than 50 copies
Exclusion criteria
* Saquinavir intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral load less than 50 copies/ml Improvement of renal functions and renal imaging | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic and cutaneous profile | 48 weeks |
Countries
Thailand
Outcome results
None listed