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

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ClinicalTrials.gov Identifier: NCT00477048
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : February 22, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
IDV Associated Nephrotoxicity Drug: Saquinavir Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2004
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Viral load less than 50 copies/ml Improvement of renal functions and renal imaging [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Metabolic and cutaneous profile [ Time Frame: 48 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT00477048     History of Changes
Other Study ID Numbers: HIV-NAT 027
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

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
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors