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

Phase 2

Withdrawn

• Conditions: Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID
• Interventions: Drug: saquinavir/ritonavir plus truvada

• Registration Number: NCT00476983
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

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 Timeline

• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-20
• Study First Posted: 2007-05-22
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	saquinavir/ritonavir plus truvada	SQV/r 1500/100 mg OD + Truvada OD

Primary Outcome Measures

Name	Time	Method
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	96 weeks

Secondary Outcome Measures

Name	Time	Method
safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC	96 weeks