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

IDV Associated Nephrotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477048
• Other study ID #: HIV-NAT 027
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2007
• Last updated: February 18, 2016
• Start date: May 2004
• Est. completion date: May 2008

Study information

• Verified date: February 2016
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• IDV Associated Nephrotoxicity

Intervention

Drug:
• Saquinavir
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI

Locations

Country	Name	City	State
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Ministry of Health, Thailand, Roche Pharma AG

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load less than 50 copies/ml Improvement of renal functions and renal imaging		48 weeks	Yes
Secondary	Metabolic and cutaneous profile		48 weeks	Yes

External Links

•   The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)