Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324688
Status:
COMPLETED
Last Update Posted:
2014-03-12
First Post:
2006-05-10
Brief Title:
Safety Study of Once a Day ART and Opiate Substitute
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Open-label Multicenter Study to Assess the Efficacy the Tolerability and the Adherence of a Once Daily QD Taken Antiretroviral Therapy ART Containing the NtRTI Tenofovir DF 300 mg in Combination With the Best Suitable Once a Day Regimen Being 1 NRTI Plus 1 PI or 1 NRTI Plus 1 NNRTI in HIV-1-infected IVDU- Patients With Opiate Substitution Being Either Antiretroviral-naive or With Suppressed Viral Load and Without a History of Virological Failure
Status:
COMPLETED
Status Verified Date:
2014-03
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:
3OD
Brief Summary:
This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV
Detailed Description:
Patients with a history of opiate abuse IVDU are not only a patient population that is frequently difficult to reach by the healthcare system but it also exhibits specific problems in HIV-treatment ART These patients frequently have a chaotic lifestyle which makes it difficult to take medications regularly Amongst the reasons for this are housing difficulties intoxication and substance abuse
The introduction of opiate substitution treatment can help to provide some structure and certainty to patients Even so IVDU patients are often started on ART later than others and have a greater tendency to have treatment interruptions and sub-optimal adherence to ART The end result can be treatment failure and the development of drug resistance
There is an unmet medical need for ART regimens that make adherence easier and may be suitable for co-administration with once-daily opiate substitution
The availability of tenofovir disoproxil fumarate DF 300 mg offers new options in the creation of once-daily regimens with reduced potential for drug-drug-interactions It is believed that it is now possible to construct viable once daily HIV treatment regimens for patients who have either never received prior therapy or who have no history of drug resistance Tenofovir DF is administered as a single 300 mg tablet once daily with food for the treatment of HIV infection This once daily dosing schedule of tenofovir DF makes it an attractive option for simplified dosing regimens in many subjects including methadone-maintained individuals infected with HIV Because many opiate-maintained subjects are required to have their methadone dosing directly observed in the clinic there is considerable interest in using directly-observed therapy DOT in such subjects Given that tenofovir is eliminated renally and methadone is predominantly hepatically metabolized the potential for a pharmacokinetic interaction is low However other antiretroviral agents with substantial renal elimination such as didanosine and stavudine have been shown to interact pharmacokinetically with methadone Thus it is important to demonstrate that tenofovir DF and methadone can be administered together safely and without concern for a pharmacokinetic interaction andor alterations in the efficacy safety or tolerability of methadone maintenance such that dose modifications would be required This can also be influenced by the other products in the combination therapy
HIVHBV coinfection is a frequent issue in this population 20 Treatment with TDF which is active against HBV could help to stabilize the chronic HBV infection even in cases with Lamivudine-resistance
The introduction of opiate substitution treatment can help to provide some structure and certainty to patients Even so IVDU patients are often started on ART later than others and have a greater tendency to have treatment interruptions and sub-optimal adherence to ART The end result can be treatment failure and the development of drug resistance
There is an unmet medical need for ART regimens that make adherence easier and may be suitable for co-administration with once-daily opiate substitution
The availability of tenofovir disoproxil fumarate DF 300 mg offers new options in the creation of once-daily regimens with reduced potential for drug-drug-interactions It is believed that it is now possible to construct viable once daily HIV treatment regimens for patients who have either never received prior therapy or who have no history of drug resistance Tenofovir DF is administered as a single 300 mg tablet once daily with food for the treatment of HIV infection This once daily dosing schedule of tenofovir DF makes it an attractive option for simplified dosing regimens in many subjects including methadone-maintained individuals infected with HIV Because many opiate-maintained subjects are required to have their methadone dosing directly observed in the clinic there is considerable interest in using directly-observed therapy DOT in such subjects Given that tenofovir is eliminated renally and methadone is predominantly hepatically metabolized the potential for a pharmacokinetic interaction is low However other antiretroviral agents with substantial renal elimination such as didanosine and stavudine have been shown to interact pharmacokinetically with methadone Thus it is important to demonstrate that tenofovir DF and methadone can be administered together safely and without concern for a pharmacokinetic interaction andor alterations in the efficacy safety or tolerability of methadone maintenance such that dose modifications would be required This can also be influenced by the other products in the combination therapy
HIVHBV coinfection is a frequent issue in this population 20 Treatment with TDF which is active against HBV could help to stabilize the chronic HBV infection even in cases with Lamivudine-resistance
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 |
|---|---|---|---|
| GS-02-1015 | None | None | None |