Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379405
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2006-09-20
Brief Title:
SaquinavirRitonavir in Single Therapy as Maintenance Treatment
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Open-label Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of SaquinavirRitonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study the efficacy of SaquinavirRitonavir when given in single therapy as maintenance therapy compared to standard HAART therapies
Detailed Description:
Different therapeutic strategies have been investigated to improve adherence to treatment and reduce toxicity Both the reduction in the number of doses and the number of daily tablets have led to an improvement in therapeutic compliance Similarly the administration of new treatment regimens with a reduced number of tablets a day and without NTRI may be clinically useful in improving compliance with HAART and limiting NTRI-associated toxicity These would comprise combinations of a PI boosted with ritonavir plus a non-Nucleoside and single therapy with PIs boosted with ritonavir
In this regard the results obtained with lopinavirritonavir and with atazanavirritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir
There are other PIs whose antiretroviral efficacy has also been demonstrated such as saquinavir but whose economic cost is much lower Furthermore saquinavir has a low toxicity profile and the availability of saquinavir 500 mg facilitates comfortable administration since it makes it possible to reduce the number of daily tablets to more than half
Moreover it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics high intrinsic potency low number of tablets low toxicity low potential of selection of resistant viral strains in combination with ritonavir and low economic cost make single therapy with the new formulation of saquinavir boosted with low doses of ritonavir a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load
In this regard the results obtained with lopinavirritonavir and with atazanavirritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir
There are other PIs whose antiretroviral efficacy has also been demonstrated such as saquinavir but whose economic cost is much lower Furthermore saquinavir has a low toxicity profile and the availability of saquinavir 500 mg facilitates comfortable administration since it makes it possible to reduce the number of daily tablets to more than half
Moreover it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics high intrinsic potency low number of tablets low toxicity low potential of selection of resistant viral strains in combination with ritonavir and low economic cost make single therapy with the new formulation of saquinavir boosted with low doses of ritonavir a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001136-47 | None | None | None |