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

Phase 2

Completed

• Conditions: IDV Associated Nephrotoxicity
• Interventions: Drug: Saquinavir

• Registration Number: NCT00477048
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Saquinavir	Replace Indinavir with SQV in patients with indinavir toxicity

Primary Outcome Measures

Name	Time	Method
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging	48 weeks

Secondary Outcome Measures

Name	Time	Method
Metabolic and cutaneous profile	48 weeks

Trial Locations

Locations (1)

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT); 🇹🇭 Bangkok, Thailand