Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg
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ClinicalTrials.gov Identifier: NCT00476983 |
Recruitment Status
:
Withdrawn
(No funding)
First Posted
: May 22, 2007
Last Update Posted
: March 30, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID | Drug: saquinavir/ritonavir plus truvada | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- written informed consent
- 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:
- Inability to understand the nature and extent of the study and the procedures required.
- ALT/ AST more than 5x upper limit
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir, ritonavir, tenofovir or emtricitabine
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- Active drug abuse

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476983
Principal Investigator: | Kiat Ruxrungtham, MD | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
Additional Information:
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00476983 History of Changes |
Other Study ID Numbers: |
HIV-NAT 041 |
First Posted: | May 22, 2007 Key Record Dates |
Last Update Posted: | March 30, 2015 |
Last Verified: | March 2015 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
saquinavir/ritonavir 1500/100 mg once daily |
Additional relevant MeSH terms:
Ritonavir Saquinavir Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |