Efficacy of Rilpivirine-based Regimens as Switch Therapy Clinical Trial
Official title:
Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients With Complete Virological Suppression: A Randomized Controlled Trial
| Verified date | September 2018 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background: Nevirapine (NVP)-based antiretroviral therapy (ART) remains to be used in
HIV-infected patients in resource limited countries despite its compliance and adverse effect
concerns. Rilpivirine (RPV), a newer non-nucleoside reverse transcriptase inhibitor, could be
used as an alternative to NVP in virologically suppressed patients. However, there has been
limited experience with switching from NVP-based to RPV-based regimens. The investigators
aimed to study efficacy and adverse events after ART switching from NVP-based to RPV-based
regimens.
Methods: A randomized controlled non-inferiority trial was conducted in HIV-infected patients
who received NVP-based regimens and had undetectable plasma HIV RNA for more than 6 months.
Patients were randomized 1:1 to continuation arm (NVP-based regimens were continued) or
switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil
fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the
regimens. Primary endpoint was HIV RNA <40 copies/mL at 48 weeks, with a non-inferiority
margin of 12%. Changes of CD4 cell counts and lipid profiles from baseline were analyzed.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | October 31, 2017 |
| Est. primary completion date | October 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Recent plasma HIV-1 RNA viral load within 6 months of the screening that was less than 40 copies/mL, and a CD4 cell count that was more than 200 cells/mm3 - Patient who treated with TDF/FTC/NVP or TDF/3TC/NVP for at least 6 month Exclusion Criteria: - patients with a history of HIV drug resistance, patients who used other drugs or drugs which interact with RPV (proton pump inhibitors, histamine H2-receptor antagonists, rifampin, antiepileptic drugs), female patients during pregnancy or breastfeeding, patients whose estimated glomerular filtration rate (eGFR)was <60 mL/min/1.73m2 [by The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (12)], and patients diagnosed with depressive or psychiatric disorders. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Aug 12. doi: 10.1111/hiv.12664. [Epub ahead of print] — View Citation
Taramasso L, Tatarelli P, Ricci E, Madeddu G, Menzaghi B, Squillace N, De Socio GV, Martinelli C, Gulminetti R, Maggi P, Orofino G, Vichi F, Di Biagio A, Bonfanti P; CISAI Study Group. Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA). BMC Infect Dis. 2018 Jul 31;18(1):357. doi: 10.1186/s12879-018-3268-5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HIV RNA viral load | HIV-1 RNA viral load was performed at 48 by using Amplicor HIV-1 Monitor Test version 1.5 (Roche, Basel, Switzerland) | week 48 | |
| Secondary | CD4 cell count | blood for CD4 cell count was performed at week 48 | week 48 | |
| Secondary | CD4 percentage | blood for CD4 percentage was performed at week 48 | week 48 | |
| Secondary | Change of total cholesterol | Change from baseline of total cholesterol was performed at week 48 | baseline and week 48 | |
| Secondary | Change of high-density lipoprotein cholesterol level (HDL-c) | Change from baseline of high-density lipoprotein cholesterol level (HDL-c) was performed at week 48 | baseline and week 48 | |
| Secondary | Change of low-density lipoprotein cholesterol level (LDL-c) | Change from baseline of low-density lipoprotein cholesterol level (LDL-c) was performed at week 48 | baseline and week 48 | |
| Secondary | Change of triglyceride | Change from baseline of triglyceride was performed at week 48 | baseline and week 48 |