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

NCT03251690 | Completed

• 1 other identifier: ID09-59-06
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sustained virological response

  maintain the undetectable HIV viral load

  12 months

Secondary Outcomes (3)

• Lipid adverse outcome

  12 months

• Neurological adverse outcome

  12 months

• Cost -saving after switching regimens

  12 months

Study Arms (2)

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

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

Drug: Tenofovir/Emtricitabine/Efavirenz

Interventions

Tenofovir/Emtricitabine/Rilpivirine DRUG

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

Also known as: TDF/FTC/RPV

Switching TDF/FTC/EFV to TDF/FTC/RPV

Tenofovir/Emtricitabine/Efavirenz DRUG

as a active comparator

Also known as: TDF/FTC/EFV

Continuing TDF/FTC/EFV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (5)

• Thai AIDS Society. Thailand National Guidelines on HIV/AIDS Treatment and Prevention 2014. Nontaburi: Bureau of AIDS, TB, and STIs, 2014.

  BACKGROUND

• 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.

  PMID: 21763936 RESULT

• 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.

  PMID: 21763935 RESULT

• 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.

  PMID: 26739573 RESULT

• 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.

  PMID: 26232000 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sirichai Wiriyatanakorn, MD

  Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

• Somneuk Sungkanuparp, MD

  Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: October 27, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05