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Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg

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ClinicalTrials.gov Identifier: NCT00476983
Recruitment Status : Withdrawn (No funding)
First Posted : May 22, 2007
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration

Study Description
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Brief Summary:
Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily.

Condition or disease Intervention/treatment Phase
Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID Drug: saquinavir/ritonavir plus truvada Phase 2 Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC [ Time Frame: 96 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. written informed consent
  2. 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:

  1. Inability to understand the nature and extent of the study and the procedures required.
  2. ALT/ AST more than 5x upper limit
  3. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  4. Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir, ritonavir, tenofovir or emtricitabine
  5. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
  6. Active drug abuse
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT00476983     History of Changes
Other Study ID Numbers: HIV-NAT 041
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 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