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OpenTrials
Completed

NCT Number: NCT00477048

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

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

Completed

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Key information

Conditions

IDV Associated Nephrotoxicity

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Bangkok, 10330, Thailand

About this study

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:

  • To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48
  • To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48
  • 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
  • To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saquinavir

Drug

SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI

Primary outcomes

  1. Viral load less than 50 copies/ml Improvement of renal functions and renal imaging

    Time frame: 48 weeks

Secondary outcomes

  1. Metabolic and cutaneous profile

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Ministry of Health, Thailand
  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 22, 2007
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.