Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
saquinavir · 11 trials · 1 indication
The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults. Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results \<50 copies/mL is reported.
Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.
The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
| Arm | Type | Description |
|---|---|---|
| saquinavir/ritonavir | EXPERIMENTAL | saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. |
| lopinavir/ritonavir | ACTIVE_COMPARATOR | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| saquinavir [Invirase] | DRUG | 1000 milligram (mg) Oral (po) twice daily (bid) |
| Lopinavir/ritonavir | DRUG | Lopinavir/ritonavir 400/100 mg po bid |
| Emtricitabine/tenofovir disoproxil fumarate | DRUG | Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd |
| Ritonavir | DRUG | 100 mg po bid |
| Saquinavir | DRUG | - |
| Zidovudine | DRUG | - |
| Zalcitabine | DRUG | - |
| Lamivudine | DRUG | - |
| Stavudine | DRUG | - |
| Didanosine | DRUG | - |
Inclusion Criteria: * adult patients \>=18 years of age; * chronic HIV-1 infection; * treatment-naive; * HIV-1 RNA viral load \>=10,000copies/mL; * women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days ...
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Saquinavir is used for the treatment of HIV infections. It is a small molecule drug being developed by Roche Holding AG (ticker: RHHBY) and is currently in Phase 3 clinical development. Saquinavir is administered in combination with other antiretroviral drugs to manage HIV infection.
Saquinavir is developed by Roche Holding AG, a pharmaceutical company traded under the ticker RHHBY. The drug is being investigated for the treatment of HIV infections and is currently in Phase 3 clinical development.
Saquinavir is in Phase 3 clinical development. It is an investigational drug for the treatment of HIV infections. While it has completed 11 clinical trials, it has not been reported as FDA approved, and its development status remains investigational.
Saquinavir has been studied in 11 completed clinical trials with a total enrollment of 8,861 participants. Notable trials include NCT00002162, a Phase 2 study comparing two formulations of saquinavir in combination with other antiretrovirals, and NCT00623597, a Phase 2 study of saquinavir/ritonavir in HIV-infected infants and children.
Saquinavir is also known as Invirase. Clinical trials, such as NCT00623597, refer to Invirase (saquinavir) in their titles, confirming that Invirase is a brand name for saquinavir. The drug is being developed by Roche Holding AG for HIV infections.