Anti-Retroviral AgentsSTEREOSNCT03251690
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression
A study testing Tenofovir/Emtricitabine/Rilpivirine and Tenofovir/Emtricitabine/Efavirenz in people with Anti-Retroviral Agents and Efavirenz, run by Mahidol University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Retroviral Agents, Efavirenz, HIV-1-infection
- What is being tested?
- Tenofovir/Emtricitabine/Rilpivirine and Tenofovir/Emtricitabine/Efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2016to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of NRTI resistance
- on medication that potentially interact with study drug
- denied to participate in the study
About this study
Official title: Switching Tenofovir/Emtricitabine/Efavirenz to Tenofovir/Emtricitabine/Rilpivirine Versus Continuing Tenofovir/Emtricitabine/Efavirenz in HIV1-infected Patients With Complete Virological Suppression
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.
Read the 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.
- Conditions
- Anti-Retroviral Agents, Efavirenz, HIV-1-infection, Sustained Virologic Response, Dyslipidemias, Rilpivirine
- Being tested
- Tenofovir/Emtricitabine/Rilpivirine, Tenofovir/Emtricitabine/Efavirenz
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir/Emtricitabine/RilpivirineDrug
Also called TDF/FTC/RPV
Tenofovir/Emtricitabine/Rilpivirine to compare the non-inferiority of efficacy and adverse effects to Tenofovir/Emtricitabine/Efavirenz in patients with virological suppression
Tenofovir/Emtricitabine/EfavirenzDrug
Also called TDF/FTC/EFV
as a active comparator
| Study group | Role | What they receive |
|---|---|---|
| Switching TDF/FTC/EFV to TDF/FTC/RPV | Experimental | 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 Receives: Drug: Tenofovir/Emtricitabine/Rilpivirine |
| Continuing TDF/FTC/EFV | Active comparator | Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz Receives: Drug: Tenofovir/Emtricitabine/Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
maintain the undetectable HIV viral load
Measured: 12 months
Secondary outcomes (3)
Lipid adverse outcome
Different in blood lipid profiles, including triglycerides, cholesterol, HDL, and LDL
Measured: 12 months
Neurological adverse outcome
Neurological adverse events such as dizziness
Measured: 12 months
Cost -saving after switching regimens
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start27 Oct 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anti-Retroviral AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirichai Wiriyatanakorn, MD, Principal investigator, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol UniversitySomneuk Sungkanuparp, MD, Principal investigator, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251690
- Sponsor's protocol ID
- ID09-59-06
- Acronym
- STEREOS
- Status last verified
- May 2019
- First submitted
- 14 Aug 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thai AIDS Society. Thailand National Guidelines on HIV/AIDS Treatment and Prevention 2014. Nontaburi: Bureau of AIDS, TB, and STIs, 2014.
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.
PubMed 21763936Cohen 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.
PubMed 21763935Thamrongwonglert 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.
PubMed 26739573Gianotti 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.
PubMed 26232000
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching Tenofovir/Emtricitabine/Efavirenz to Tenofovir/Emtricitabine/Rilpivirine Versus Continuing Tenofovir/Emtricitabine/Efavirenz in HIV1-infected Patients With Complete Virological Suppression
- ClinicalTrials.gov ID
- NCT03251690
- Acronym / sponsor ID
- STEREOS / ID09-59-06
- Conditions
- Anti-Retroviral Agents, Efavirenz, HIV-1-infection, Sustained Virologic Response, Dyslipidemias, Rilpivirine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switching TDF/FTC/EFV to TDF/FTC/RPV | Experimental | Drug: Tenofovir/Emtricitabine/RilpivirineSwitching 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 TDF/FTC/EFV | Active comparator | Drug: Tenofovir/Emtricitabine/EfavirenzContinuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- history of NRTI resistance
- on medication that potentially interact with study drug
- denied to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir/Emtricitabine/RilpivirineAlso: TDF/FTC/RPVTenofovir/Emtricitabine/Rilpivirine to compare the non-inferiority of efficacy and adverse effects to Tenofovir/Emtricitabine/Efavirenz in patients with virological suppression | Drug | Switching TDF/FTC/EFV to TDF/FTC/RPV |
| Tenofovir/Emtricitabine/EfavirenzAlso: TDF/FTC/EFVas a active comparator | Drug | Continuing TDF/FTC/EFV |
Primary outcome
Sustained virological response
Time frame: 12 months
maintain the undetectable HIV viral load
3 secondary outcomes
Lipid adverse outcome
Time frame: 12 months
Neurological adverse outcome
Time frame: 12 months
Cost -saving after switching regimens
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- BackgroundThai AIDS Society. Thailand National Guidelines on HIV/AIDS Treatment and Prevention 2014. Nontaburi: Bureau of AIDS, TB, and STIs, 2014.
- Results publication: PubMed 21763936Molina 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 publication: PubMed 21763935Cohen 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 publication: PubMed 26739573Thamrongwonglert 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 publication: PubMed 26232000Gianotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirichai Wiriyatanakorn, MD principal investigator
Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Somneuk Sungkanuparp, MD principal investigator
Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir/Emtricitabine/Rilpivirine and Tenofovir/Emtricitabine/Efavirenz in people with Anti-Retroviral Agents and Efavirenz, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251690, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.