A Phase 2/3 interventional study of saquinavir/ritonavir plus truvada in Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID, sponsored by The HIV Netherlands Australia Thailand Research Collaboration. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-30.
Sponsored by The HIV Netherlands Australia Thailand Research Collaboration · Phase 2/3, Interventional, and Treatment
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
The HIV Netherlands Australia Thailand Research Collaboration is the lead sponsor of 60 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
SQV/r 1500/100 mg OD + Truvada OD
Drug: saquinavir/ritonavir plus truvada
Drug pages: Saquinavir · Ritonavir
SQV/r 1500/100 mg OD + Truvada OD for 2 years
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
safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC
Time frame: 96 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Saquinavir · Ritonavir
The HIV Netherlands Australia Thailand Research Collaboration