Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BIDPhase 2/3NCT00476983
Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg
A Phase 2/3 study testing saquinavir/ritonavir plus truvada in people with Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID, run by The HIV Netherlands Australia Thailand Research Collaboration.
Trial summary
Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID
- What is being tested?
- saquinavir/ritonavir plus truvada
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- All adults HIV patients previously included in the Gemini study and are currently enrolled in HIV-NAT 006 and treated with SQV /r 1500/100 mg OD plus tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily
Who cannot join
- Inability to understand the nature and extent of the study and the procedures required.
- ALT/ AST more than 5x upper limit
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir, ritonavir, tenofovir or emtricitabine
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- Active drug abuse
About this study
Official title: Pharmacokinetic and Efficacy of Saquinavir Mesylate Film Coated Tablet / Ritonavir 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg Once Daily in HIV Pretreated Patients
Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily.
Read the detailed description
This study will be performed in patients who were previously treated with SQV /r 1000/100mg twice daily or Lopinavir/r plus TDF/FTC once daily as part of the Gemini study. After 48 weeks of the study, the patients will be treated with SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily with good CD4 and VL outcomes. In this study, we would like to evaluate the once-daily dosing of SQV using SQV- SQV film coated tablet 1500/ritonavir 100mg in combination with TDF/FTC300/200mg once daily. We believe that the PK parameters of SQV given at 1500mg daily will be equivalent to the 1000mg twice daily dosing when combined with RTV and TDF/FTC300/200mg OD, and that the once daily regimen will have better safety, tolerability profile than the twice daily regimen while maintaining good CD4 and VL outcome
- Being tested
- saquinavir/ritonavir plus truvada
- Keywords
- saquinavir/ritonavir 1500/100 mg once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saquinavir/ritonavir plus truvadaDrug
SQV/r 1500/100 mg OD + Truvada OD for 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SQV/r 1500/100 mg OD + Truvada OD Receives: Drug: saquinavir/ritonavir plus truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of saquinavir mesylate film-coated tablet 1500 mg once daily dosing when used in combination with ritonavir 100 mg, and tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily
Measured: 96 weeks
Secondary outcomes (1)
safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC
Measured: 96 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)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BIDStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- 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
- NCT00476983
- Sponsor's protocol ID
- HIV-NAT 041
- Status last verified
- Mar 2015
- First submitted
- 20 May 2007
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Efficacy of Saquinavir Mesylate Film Coated Tablet / Ritonavir 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg Once Daily in HIV Pretreated Patients
- ClinicalTrials.gov ID
- NCT00476983
- Acronym / sponsor ID
- HIV-NAT 041
- Keywords
- saquinavir/ritonavir 1500/100 mg once daily
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- 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.
Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily.
Detailed description
This study will be performed in patients who were previously treated with SQV /r 1000/100mg twice daily or Lopinavir/r plus TDF/FTC once daily as part of the Gemini study. After 48 weeks of the study, the patients will be treated with SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily with good CD4 and VL outcomes. In this study, we would like to evaluate the once-daily dosing of SQV using SQV- SQV film coated tablet 1500/ritonavir 100mg in combination with TDF/FTC300/200mg once daily. We believe that the PK parameters of SQV given at 1500mg daily will be equivalent to the 1000mg twice daily dosing when combined with RTV and TDF/FTC300/200mg OD, and that the once daily regimen will have better safety, tolerability profile than the twice daily regimen while maintaining good CD4 and VL outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: saquinavir/ritonavir plus truvadaSQV/r 1500/100 mg OD + Truvada OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written informed consent
- All adults HIV patients previously included in the Gemini study and are currently enrolled in HIV-NAT 006 and treated with SQV /r 1500/100 mg OD plus tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily
Key exclusion criteria (6 listed)
- Inability to understand the nature and extent of the study and the procedures required.
- ALT/ AST more than 5x upper limit
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir, ritonavir, tenofovir or emtricitabine
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
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 |
|---|---|---|
| saquinavir/ritonavir plus truvadaSQV/r 1500/100 mg OD + Truvada OD for 2 years | Drug | 1 |
Primary outcome
Pharmacokinetics of saquinavir mesylate film-coated tablet 1500 mg once daily dosing when used in combination with ritonavir 100 mg, and tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily
Time frame: 96 weeks
1 secondary outcome
safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC
Time frame: 96 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- 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)
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing saquinavir/ritonavir plus truvada in people with Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID, run by The HIV Netherlands Australia Thailand Research Collaboration.
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 6 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: withdrawn, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetics of saquinavir mesylate film-coated tablet 1500 mg once daily dosing when used in combination with ritonavir 100 mg, and tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily (time frame: 96 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 30 Mar 2015.