Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression

Not Applicable

Completed

• Conditions: Anti-Retroviral Agents; HIV-1-infection; Sustained Virologic Response; Rilpivirine; Efavirenz; Dyslipidemias
• Interventions: Drug: Tenofovir/Emtricitabine/Rilpivirine; Drug: Tenofovir/Emtricitabine/Efavirenz

• Registration Number: NCT03251690
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-10-27
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-04
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

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Exclusion Criteria

• history of NRTI resistance
• on medication that potentially interact with study drug
• denied to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switching TDF/FTC/EFV to TDF/FTC/RPV	Tenofovir/Emtricitabine/Rilpivirine	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 TDF/FTC/EFV	Tenofovir/Emtricitabine/Efavirenz	Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz

Primary Outcome Measures

Name	Time	Method
Sustained virological response	12 months	maintain the undetectable HIV viral load

Secondary Outcome Measures

Name	Time	Method
Lipid adverse outcome	12 months	Different in blood lipid profiles, including triglycerides, cholesterol, HDL, and LDL
Neurological adverse outcome	12 months	Neurological adverse events such as dizziness
Cost -saving after switching regimens	12 months