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Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg
This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476983
First received: May 20, 2007
Last updated: March 27, 2015
Last verified: March 2015
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Purpose
Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily.
| Condition | Intervention | Phase |
|---|---|---|
| Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID | Drug: saquinavir/ritonavir plus truvada | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC [ Time Frame: 96 weeks ]
| Enrollment: | 0 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
SQV/r 1500/100 mg OD + Truvada OD
|
Drug: saquinavir/ritonavir plus truvada
SQV/r 1500/100 mg OD + Truvada OD for 2 years
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476983
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476983
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
More Information
Additional Information:
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT00476983 History of Changes |
| Other Study ID Numbers: |
HIV-NAT 041 |
| Study First Received: | May 20, 2007 |
| Last Updated: | March 27, 2015 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
saquinavir/ritonavir 1500/100 mg once daily |
Additional relevant MeSH terms:
|
Ritonavir Saquinavir Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017