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

Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00476983
• Other study ID #: HIV-NAT 041
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: May 20, 2007
• Last updated: March 27, 2015

Study information

• Verified date: March 2015
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID

Intervention

Drug:
• saquinavir/ritonavir plus truvada
SQV/r 1500/100 mg OD + Truvada OD for 2 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	safety, tolerability and efficacy of SQV /r 1500/100 once daily when use with TDF/FTC		96 weeks	Yes

External Links

•   The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)