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

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 2

Conditions: IDV Associated Nephrotoxicity

Treatments: Drug: Saquinavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00477048

HIV-NAT 027

Details and patient eligibility

About

Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Other group

Description:

Replace Indinavir with SQV in patients with indinavir toxicity

Treatment:

Drug: Saquinavir