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This study has been withdrawn prior to enrollment.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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier: NCT00476983     History of Changes
Other Study ID Numbers: HIV-NAT 041
Study First Received: May 20, 2007
Last Updated: June 4, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
saquinavir/ritonavir 1500/100 mg once daily

Additional relevant MeSH terms:
Saquinavir
Ritonavir
Tenofovir
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014