Efficacy and Safety of SQV in Patients Who Have Chronic I... | NCT00477048

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

NCT00477048

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Status

Completed

Last Update Posted

Feb 22, 2016Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

IDV Associated Nephrotoxicity

Interventions

Saquinavir

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

May 20, 2007

First Submission Date that Met QC Criteria

May 21, 2007

First Posted Date

May 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2016

Last Update Posted Date

Feb 22, 2016Estimated

Name	Class
Roche Pharma AG	INDUSTRY
Ministry of Health, Thailand	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Replace Indinavir with SQV in patients with indinavir toxicity	Drug: Saquinavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saquinavir	Drug	SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging		48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Metabolic and cutaneous profile		48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kiat Ruxrungtham, MD	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)		Bangkok	Bangkok	10330	Thailand

References Module

Citations

Not provided

ID	Term
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds