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This study has been withdrawn prior to enrollment.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:
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476983
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
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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 ] [ Designated as safety issue: Yes ]
Pharmacokinetics of saquinavir mesylate film-coated tablet 1500 mg once daily dosing when used in combination with ritonavir 100 mg, and tenofovir/emticitabine (TDF/FTC) 300/200 mg once daily [ Time Frame: 96 weeks ]
Complete list of historical versions of study NCT00476983 on ClinicalTrials.gov Archive Site
safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC [ Time Frame: 96 weeks ]
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Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg
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.

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

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID
Drug: saquinavir/ritonavir plus truvada
SQV/r 1500/100 mg OD + Truvada OD for 2 years
Experimental: 1
SQV/r 1500/100 mg OD + Truvada OD
Intervention: Drug: saquinavir/ritonavir plus truvada
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
56
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00476983
HIV-NAT 041
Yes
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Not Provided
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP