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

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma AG
Ministry of Health, Thailand
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00477048
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
May 2004
May 2008   (final data collection date for primary outcome measure)
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00477048 on ClinicalTrials.gov Archive Site
Metabolic and cutaneous profile [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Metabolic and cutaneous profile [ Time Frame: 48 weeks ]
Not Provided
Not Provided
 
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.

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

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
IDV Associated Nephrotoxicity
Drug: Saquinavir
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
1
Replace Indinavir with SQV in patients with indinavir toxicity
Intervention: Drug: Saquinavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00477048
HIV-NAT 027
Yes
Prof. Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • Roche Pharma AG
  • Ministry of Health, Thailand
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP