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
  Purpose

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


Condition Intervention Phase
IDV Associated Nephrotoxicity
Drug: Saquinavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • Viral load less than 50 copies/ml Improvement of renal functions and renal imaging [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Metabolic and cutaneous profile [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Replace Indinavir with SQV in patients with indinavir toxicity
Drug: Saquinavir
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI

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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477048

Locations
Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Roche Pharma AG
Ministry of Health, Thailand
Investigators
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier: NCT00477048     History of Changes
Other Study ID Numbers: HIV-NAT 027
Study First Received: May 20, 2007
Last Updated: June 4, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
IDV nephrotoxicity

Additional relevant MeSH terms:
Saquinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014