NCT00477048

Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity

Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• IDV Associated Nephrotoxicity

Interventions

Type	Name	Description
DRUG	Saquinavir	SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-05-22
• Last updated: 2016-02-22

Locations

1 site across 1 country: Thailand