Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300573
Status:
TERMINATED
Last Update Posted:
2018-08-23
First Post:
2006-03-07
Brief Title:
Randomized Double-Blind Study Comparing Dexelvucitabine DFC to Lamivudine 3TC in Subjects With Resistance to NRTIs PIs and NNRTIs
Sponsor:
Incyte Corporation
Organization:
Incyte Corporation
Study Overview
Official Title:
A Randomized Double-Blind Phase II Study Comparing the Anti-Retroviral Safety and Efficacy of Dexelvucitabine DFC 200 mg Once Daily to Lamivudine 3TC 300 mg Once Daily in Addition to Optimized Background Therapy in HIV-1 Infected Subjects Who Have Failed andor Harbor HIV With Resistance Mutations to NRTIs PIs and NNRTIs
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Development program ended due to inability to pair with other cytidine analogs and higher risk of hyperlipasemia when not used with 3TCFTC
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECLARE
Brief Summary:
The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor NRTI dexelvucitabine DFC to an approved NRTI lamivudine 3TC in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies NRTIs PIs and NNRTIs Patients meeting eligibility requirements will have a new optimized background regimen OBR selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period In addition to treatment with the new OBR patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion There is a 50 percent chance a patient will receive DFC or 3TC Treatment in the study may continue for up to 96 weeks Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication ie DFC to 3TC or 3TC to DFC
Detailed Description:
The study will compare the safety and efficacy of an investigational nucleoside analog reverse transcriptase inhibitor NRTI dexelvucitabine DFC 200 mg once daily to an approved NRTI lamivudine 3TC 300 mg once daily in treatment experienced patients with HIV that is resistant to 3 classes of antiretroviral therapies NRTIs PIs and NNRTIs Patients meeting eligibility requirements will have a new optimized background regimen OBR selected for them based on prior treatment history and results of HIV genotype and phenotype performed during screening In addition to the OBR patients will be randomized to receive at at one to one ratio DFC or 3TC in a blinded fashion The OBR may include any approved HIV treatments except 3TC FTC ddI d4T and ddC Medications available through expanded access may also be available to selected patients Treatment in the study will continue for up to 96 weeks with primary endpoints at 24 and 48 weeks of therapy Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch study medication DFC to 3TC or 3TC to DFC A total of 250 patients will be enrolled
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 |
|---|---|---|---|
| EudraCT 2006-000096-16 | None | None | None |