Switch to Genvoya Followed by HCV Therapy With Epclusa in Patients With HIV/HCV Co-Infection on Methadone
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|ClinicalTrials.gov Identifier: NCT03549312|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection Hepatitis C, Chronic Intravenous Drug Usage Methadone Dependence Opioid Dependence Drug Abuse Bone Diseases, Metabolic HIV/AIDS Co-infection||Drug: Genvoya Drug: Epclusa||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (ECF/TAF) Switch Followed by Sofosbuvir/Velpatasvir (SOF/VEL) Antiviral HCV Therapy in HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Switch to Genvoya Followed By HCV Therapy With Epclusa
Oral Genvoya 150/150/200/10 mg & Epclusa 400/100 mg once daily
Switching to Genvoya for 12 weeks in patients with HIV/HCV co-infection and stably suppressed HIV RNA, prior to starting HCV treatment, while receiving methadone as opioid substitution therapy.
Plasma HIV-1 RNA < 50 copies/mL at weeks 12 and 48.
Other Name: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide
HCV therapy with direct-acting-antiviral therapy with Epclusa in HIV-HCV co-infected patients with suppressed HIV RNA, receiving methadone as opioid substitution therapy.
Other Name: Sofosbuvir and Velpatasvir
- Feasibility assessment: participants approached, screened and enrolled in the study along with completed study visits [ Time Frame: Up to 48 weeks on Genvoya and 12 weeks of Epclusa ]Feasibility will be measured by collecting data on the number of participants approached, screened and enrolled. In addition, feasibility will be assessed by proportion of completed study visits as outlined in the protocol.
- Adherence [ Time Frame: Week 48 ]Adherence will be assessed at every study visit using pill counts for returned study medication bottles as well as missed doses reported on medication diaries. Altogether, this data will be compiled and analyzed at the end of the study.
- HIV treatment outcome [ Time Frame: Week 12 ]Proportion of participants with suppressed HIV Viral Load (i.e. plasma HIV-1 RNA < 50 copies/mL) prior to starting HCV therapy.
- Sustained HIV Viral Load Suppression [ Time Frame: Week 48 ]Proportion of participants who maintain suppressed HIV Viral Load (i.e. plasma HIV-1 RNA < 50 copies/mL)
- HCV treatment outcome [ Time Frame: Week 24 ]Proportion of participants who achieve suppressed virologic response.
- Maintenance of HCV Clearance [ Time Frame: Week 48 ]Proportion of participation who maintain a suppressed virologic response
- Other treatment Outcomes [ Time Frame: Week 48 ]Proportion of participants who complete all study protocol procedures.
- Other treatment Outcomes [ Time Frame: 48 weeks ]Record all adverse events experienced by participants from the beginning of the study until the end of the study.
- HCV clearance post Epclusa therapy [ Time Frame: Weeks 24 and 48 ]Proportion of participants with HCV RNA <12 copies/mL (c/mL) at Week 24 and Week 48
- HIV Incidence of Virologic Failure [ Time Frame: Week 48 ]Proportion of participants with confirmed virologic failure (two consecutive plasma HIV-1 RNA levels ≥200 c/mL after prior suppression to <200 c/mL) at Week 48
- Immunologic Responses [ Time Frame: 48 weeks ]Absolute values and change from baseline in plasma HIV-1 RNA (log10 c/mL) to end of treatment
- Immunologic Responses [ Time Frame: 48 weeks ]Absolute values and change from baseline in CD4+ lymphocyte count to end of treatment
- Number of participants with treatment-related safety problems or adverse events assessed using renal laboratory testing [ Time Frame: Weeks 0 and 48 ]
- Number of participants with treatment-related adverse reaction using bone mineral densitometry tests [ Time Frame: Weeks 0 and 48 ]
- Adjustments to methadone dosing over study duration [ Time Frame: 48 weeks ]Proportion of participants who required changes in the methadone dosing and deemed a secondary consequence of either Genvoya or Epculsa treatment
- Opioid withdrawal or overdose symptoms over study duration [ Time Frame: 48 weeks ]Proportion of participants who experience opioid withdrawal or overdose symptoms while receiving either Genvoya and/or Epculsa treatments
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549312
|Contact: Alexander Wong, MDfirstname.lastname@example.org|
|Contact: Dennaye Fuchs, RNemail@example.com|
|Saskatchewan Health Authority||Recruiting|
|Regina, Saskatchewan, Canada, S4P 0W5|
|Contact: Alexander Wong, MD 306-766-3915 firstname.lastname@example.org|
|Contact: Dennaye Fuchs, RN 306-766-4521 email@example.com|
|Principal Investigator: Alexander Wong, MD|
|Sub-Investigator: Stuart Skinner, MD|
|Sub-Investigator: Kumudhini Karunakaran, MD|
|Principal Investigator:||Alexander Wong, MD||Saskatchewan Health Authority - Regina Area|