Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
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
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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:
- 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
![](https://webarchive.library.unt.edu/web/20130312001108im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20130312001108im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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) |
![](https://webarchive.library.unt.edu/web/20130312001108im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 March 10, 2013