Safety Study of Once a Day ART and Opiate Substitute. (3OD)
|First Received Date ICMJE||May 10, 2006|
|Last Updated Date||June 30, 2008|
|Start Date ICMJE||March 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00324688 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety Study of Once a Day ART and Opiate Substitute.|
|Official Title ICMJE||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|
This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV.
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 and/or 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.
HIV/HBV 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 Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Viread|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Germany|
|NCT Number ICMJE||NCT00324688|
|Other Study ID Numbers ICMJE||GS-MC-104-1015, GS-02-1015|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Gilead Sciences|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Gilead Sciences|
|Verification Date||June 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP