Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression (STEREOS)
Primary Purpose
Anti-Retroviral Agents, Efavirenz, HIV-1-infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tenofovir/Emtricitabine/Rilpivirine
Tenofovir/Emtricitabine/Efavirenz
Sponsored by

About this trial
This is an interventional treatment trial for Anti-Retroviral Agents
Eligibility Criteria
Inclusion Criteria:
- on TDF/FTC/EFV for more than 3 months
- Blood HIV RNA viral load <50 copies/mL
- CD4+ count >200 cells/mm3
- eligible to sign the informed consent
Exclusion Criteria:
- history of NRTI resistance
- on medication that potentially interact with study drug
- denied to participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Switching TDF/FTC/EFV to TDF/FTC/RPV
Continuing TDF/FTC/EFV
Arm Description
Switching from Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day (once daily) to Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Rilpivirine 25 mg/day (once daily) Intervention: Tenofovir/Emtricitabine/Rilpivirine
Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz
Outcomes
Primary Outcome Measures
Sustained virological response
maintain the undetectable HIV viral load
Secondary Outcome Measures
Lipid adverse outcome
Different in blood lipid profiles, including triglycerides, cholesterol, HDL, and LDL
Neurological adverse outcome
Neurological adverse events such as dizziness
Cost -saving after switching regimens
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03251690
Brief Title
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression
Acronym
STEREOS
Official Title
Switching Tenofovir/Emtricitabine/Efavirenz to Tenofovir/Emtricitabine/Rilpivirine Versus Continuing Tenofovir/Emtricitabine/Efavirenz in HIV1-infected Patients With Complete Virological Suppression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed the non-inferiority of RPV compared with EFV in naive cases. But there were not much randomized-controlled trials for changing from other NRTI to RPV in patients who currently on another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.
Detailed Description
According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART (Anti-retroviral therapy) regimen was 2 NRTIs (nucleoside reverse transcriptase inhibitors) backbone, which are TDF (Tenofovir) and FTC (Emtricitabine); plus 1 NNRTI (non-nucleoside reverse transcriptase inhibitor), which is EFV (Efavirenz), with RPV (Rilpivirine) as an alternative in this class of drug.
Most of the randomized-controlled studies, including ECHO (Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1) and THRIVE (Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1), the major trials about RPV, showed the non-inferiority in efficacy of RPV compared with that of EFV in treatment-naive cases with blood HIV viral load less than 500,000 copies/mL. But there were not many trials focusing on changing the ART-regimens from other NRTI to RPV in patients who currently on another ART, especially in randomized-controlled design. There were some studies comparing continuing current regimens versus changing to Rilpivirine-based regimens, but they didn't exclusively select the homogeneous drug components. In Thailand, study of changing to Rilpivirine-based regimens was primarily designed to evaluate the adverse outcome about dyslipidemia, whereas efficacy was a secondary outcome. Most studies, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.
Therefore, we design this study to evaluate the efficacy; in term of non-inferiority, of the newer, safer, and cheaper drug, Rilpivirine, to Efavirenz, the general-use drug with acceptable efficacy, in the virological-suppressed patients currently on ART. Besides, we also assess the adverse outcomes and factors associated with successful or failure of treatment. In addition, we can have more backup data in term of national economics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Retroviral Agents, Efavirenz, HIV-1-infection, Sustained Virologic Response, Dyslipidemias, Rilpivirine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Switching TDF/FTC/EFV to TDF/FTC/RPV
Arm Type
Experimental
Arm Description
Switching from Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day (once daily) to Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Rilpivirine 25 mg/day (once daily) Intervention: Tenofovir/Emtricitabine/Rilpivirine
Arm Title
Continuing TDF/FTC/EFV
Arm Type
Active Comparator
Arm Description
Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz
Intervention Type
Drug
Intervention Name(s)
Tenofovir/Emtricitabine/Rilpivirine
Other Intervention Name(s)
TDF/FTC/RPV
Intervention Description
Tenofovir/Emtricitabine/Rilpivirine to compare the non-inferiority of efficacy and adverse effects to Tenofovir/Emtricitabine/Efavirenz in patients with virological suppression
Intervention Type
Drug
Intervention Name(s)
Tenofovir/Emtricitabine/Efavirenz
Other Intervention Name(s)
TDF/FTC/EFV
Intervention Description
as a active comparator
Primary Outcome Measure Information:
Title
Sustained virological response
Description
maintain the undetectable HIV viral load
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lipid adverse outcome
Description
Different in blood lipid profiles, including triglycerides, cholesterol, HDL, and LDL
Time Frame
12 months
Title
Neurological adverse outcome
Description
Neurological adverse events such as dizziness
Time Frame
12 months
Title
Cost -saving after switching regimens
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
on TDF/FTC/EFV for more than 3 months
Blood HIV RNA viral load <50 copies/mL
CD4+ count >200 cells/mm3
eligible to sign the informed consent
Exclusion Criteria:
history of NRTI resistance
on medication that potentially interact with study drug
denied to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirichai Wiriyatanakorn, MD
Organizational Affiliation
Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Somneuk Sungkanuparp, MD
Organizational Affiliation
Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
Thai AIDS Society. Thailand National Guidelines on HIV/AIDS Treatment and Prevention 2014. Nontaburi: Bureau of AIDS, TB, and STIs, 2014.
Results Reference
background
PubMed Identifier
21763936
Citation
Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46. doi: 10.1016/S0140-6736(11)60936-7.
Results Reference
result
PubMed Identifier
21763935
Citation
Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011 Jul 16;378(9787):229-37. doi: 10.1016/S0140-6736(11)60983-5.
Results Reference
result
PubMed Identifier
26739573
Citation
Thamrongwonglert P, Chetchotisakd P, Anunnatsiri S, Mootsikapun P. Improvement of lipid profiles when switching from efavirenz to rilpivirine in HIV-infected patients with dyslipidemia. HIV Clin Trials. 2016 Feb;17(1):12-6. doi: 10.1080/15284336.2015.1112480. Epub 2016 Jan 7.
Results Reference
result
PubMed Identifier
26232000
Citation
Gianotti N, Poli A, Nozza S, Spagnuolo V, Tambussi G, Bossolasco S, Cinque P, Maillard M, Cernuschi M, Galli L, Lazzarin A, Castagna A. Efficacy and safety in clinical practice of a rilpivirine, tenofovir and emtricitabine single-tablet regimen in virologically suppressed HIV-positive patients on stable antiretroviral therapy. J Int AIDS Soc. 2015 Jul 30;18(1):20037. doi: 10.7448/IAS.18.1.20037. eCollection 2015.
Results Reference
result
Learn more about this trial
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression
We'll reach out to this number within 24 hrs