NCT00477048

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

4 years

First QC Date

May 20, 2007

Last Update Submit

February 18, 2016

Conditions

IDV Associated Nephrotoxicity

Keywords

IDV nephrotoxicity

Outcome Measures

Primary Outcomes (1)

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

    48 weeks

Secondary Outcomes (1)

  • Metabolic and cutaneous profile

    48 weeks

Study Arms (1)

1

OTHER

Replace Indinavir with SQV in patients with indinavir toxicity

Drug: Saquinavir

Interventions

SaquinavirDRUG

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

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Saquinavir intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok, Bangkok, 10330, Thailand

Location

Related Links

MeSH Terms

Interventions

Saquinavir

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolines

Study Officials

  • Kiat Ruxrungtham, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

May 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

TH(1)