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

NCT03251690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2019-05-07

No results posted yet for this study

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.

Conditions

  • Anti-Retroviral Agents
  • Efavirenz
  • HIV-1-infection
  • Sustained Virologic Response
  • Dyslipidemias
  • Rilpivirine

Interventions

DRUG

Tenofovir/Emtricitabine/Rilpivirine

Tenofovir/Emtricitabine/Rilpivirine to compare the non-inferiority of efficacy and adverse effects to Tenofovir/Emtricitabine/Efavirenz in patients with virological suppression

DRUG

Tenofovir/Emtricitabine/Efavirenz

as a active comparator

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Sirichai Wiriyatanakorn, MD · Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

  • Somneuk Sungkanuparp, MD · Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-27
Primary Completion
2018-04-30
Completion
2018-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03251690 on ClinicalTrials.gov