IDV Associated NephrotoxicityPhase 2NCT00477048
Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity
A Phase 2 study testing Saquinavir in people with IDV Associated Nephrotoxicity, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IDV Associated Nephrotoxicity
- What is being tested?
- Saquinavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- May 2004to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Saquinavir intolerance
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Bangkok, 10330
About this study
Official title: Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.
Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.
Read the 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
- Conditions
- IDV Associated Nephrotoxicity
- Being tested
- Saquinavir
- Keywords
- IDV nephrotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaquinavirDrug
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Replace Indinavir with SQV in patients with indinavir toxicity Receives: Drug: Saquinavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
Measured: 48 weeks
Secondary outcomes (1)
Metabolic and cutaneous profile
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IDV Associated NephrotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477048
- Sponsor's protocol ID
- HIV-NAT 027
- Status last verified
- Feb 2016
- First submitted
- 20 May 2007
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.
- ClinicalTrials.gov ID
- NCT00477048
- Acronym / sponsor ID
- HIV-NAT 027
- Conditions
- IDV Associated Nephrotoxicity
- Keywords
- IDV nephrotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Ministry of Health, Thailand
- Study start
- May 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: SaquinavirReplace Indinavir with SQV in patients with indinavir toxicity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Saquinavir intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaquinavirSQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI | Drug | 1 |
Primary outcome
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
Time frame: 48 weeks
1 secondary outcome
Metabolic and cutaneous profile
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiat Ruxrungtham, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saquinavir in people with IDV Associated Nephrotoxicity, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.