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- || Vocabria (cabotegravir oral) / ViiV Healthcare
Trial completion date: LATTE-2: A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects (clinicaltrials.gov) - Feb 23, 2020
P2b, N=309, Active, not recruiting, Sponsor: ViiV Healthcare
Trial completion date: Dec 2020 --> Feb 2022
- | Tivicay (dolutegravir) / ViiV Healthcare
Review, Journal: Antiretroviral agents in pre-exposure prophylaxis: emerging and advanced trends in HIV prevention. (Pubmed Central) - Feb 22, 2020
Some of the most common pre-exposure prophylactic strategies employed currently are the use of inhibitors, namely entry inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, integrase and protease inhibitors. In addition, we have also discussed on the adverse effects caused by ART in PrEP, pharmacoeconomics factors and the use of antiretroviral prophylaxis in serodiscordant couples.
- | Edurant (rilpivirine) / J&J, Intelence (etravirine) / J&J
Journal: Fragment hopping-based discovery of novel sulfinylacetamide-diarylpyrimidines (DAPYs) as HIV-1 nonnucleoside reverse transcriptase inhibitors. (Pubmed Central) - Feb 21, 2020
In addition, this compound showed a favorable in vitro microsomal stability across species. Computational study predicted the binding models of these potent compounds with HIV-1 reverse transcriptase thus providing further insights for new developments.
- Edurant (rilpivirine) / J&J
Investigations on Zika virus suppression by rilpivirine: Story of drug repurposing (Exhibit Hall D, Pennsylvania Convention Center) - Feb 13, 2020 - Abstract #ACSSp2020ACS_Sp_12903;
Our work shed light on the molecular underpinnings of ZIKV inhibition by a currently approved drug, thereby offering a concrete therapeutic strategy for the treatment of ZIKV associated disease. Additionally, by characterizing a drug binding pocket in the palm site of the NS5 protein, our results opened the doors to the rational design of new and improved ZIKV inhibitors.
- cabotegravir (GSK1265744) / ViiV Healthcare, Edurant (rilpivirine) / J&J
Assembling RPV and CAB loaded HIV-1 mimicking GM3-functionalized lipid-wrapped polymer NPs to inhibit HIV-1 infection by targeting non-lysosomal compartments in CD169+ macrophages and dendritic cells (Exhibit Hall A, Pennsylvania Convention Center) - Feb 13, 2020 - Abstract #ACSSp2020ACS_Sp_12203;
Furthermore, we monitored the intracellular fate of GM3 PLA NPs in monocyte derived macrophages (MDMs) after 12 days, and our data confirmed the successful retention of NPs in non-lysosomal compartments during the chosen experimental duration. These findings underline the role of core stiffness for intracellular NP targeting and pave the way to a specific targeting of non-lysosomal compartments in CD169 expressing macrophages and dendritic cells in future in-vivo studies.
- ||| Edurant (rilpivirine) / J&J
Clinical: The switch from TDF to TAF determines weight gain in patients on rilpivirine-based regimen. - Switching to TAF from TDF in virally suppressed PWH appears to have a similar impact on weight as it does in naive starting ART @AIDS_Journal https://t.co/OMe7ORayQ1 (Twitter) - Feb 9, 2020
- || Edurant (rilpivirine) / J&J, emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Clinical, Journal: The switch from TDF to TAF determines weight gain in patients on rilpivirine-based regimen. (Pubmed Central) - Feb 8, 2020
These findings underline the role of core stiffness for intracellular NP targeting and pave the way to a specific targeting of non-lysosomal compartments in CD169 expressing macrophages and dendritic cells in future in-vivo studies. TAF appears to have an impact on weight gain, similarly to what observed in naïve patients, also in experienced PLWHIV with good virologic control.
- ||| Edurant (rilpivirine) / J&J
Clinical: The switch from TDF to TAF determines weight gain in patients on rilpivirine-based regimen https://t.co/e0wYYQJpBR (Twitter) - Feb 8, 2020
- | Vemlidy (tenofovir alafenamide) / Gilead
Journal: Creating demand for long-acting formulations for the treatment and prevention of HIV, tuberculosis, and viral hepatitis. (Pubmed Central) - Feb 7, 2020
These products hold great promise for the global control of important human infections. Based on experience with other diseases, it is likely that their use will become more widespread if they are cost competitive with generic oral formulations.
- simvastatin / Generic mfg., Edurant (rilpivirine) / J&J
A SYNERGISTIC EFFECT BETWEEN RILPIVIRINE AND SIMVASTATIN IN THE CONTEXT OF LEADER FIBROGENESIS IN VITRO () - Jan 27, 2020 - Abstract #AEEH2020AEEH_166;
- | Edurant (rilpivirine) / J&J
Trial completion date: A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years (clinicaltrials.gov) - Jan 22, 2020
P2, N=61, Recruiting, Sponsor: Janssen Sciences Ireland UC
Based on experience with other diseases, it is likely that their use will become more widespread if they are cost competitive with generic oral formulations. Trial completion date: Aug 2027 --> Aug 2022
- | lamivudine / Generic mfg.
Journal: Antiretroviral Treatment Simplification With 2-Drug Regimens: Impact of Transmitted Drug Resistance Mutations. (Pubmed Central) - Jan 11, 2020
The frequency of clinically relevant transmitted drug resistance mutations (DRMs) against drugs used for 2-drug regimens was 15.6%, but only 2% were not eligible for 1 or more 2-drug regimens. More than 50% of patients harboring any clinically relevant DRMs were found to be part of genetic transmission clusters.
- | Edurant (rilpivirine) / J&J
Preclinical, Journal: Effects of rilpivirine, 17β-estradiol and β-naphthoflavone on the inflammatory status of release of adipocytokines in 3T3-L1 adipocytes in vitro. (Pubmed Central) - Jan 8, 2020
In contrast, BNF pretreatment had little of no effect on either leptin, resistin or IL-8 metabolism compared to the results obtained in the presence of either rilpivirine or estradiol alone or in combination.These results show that rilpivirine and estradiol either alone or when combined or pretreated with BNF can evoke marked effects on glycerol and cytokines levels from adipocytes. However, their mechanism (s) in inducing adipogenesis warrants further investigation of different transcription factors at gene expression levels.
- | Edurant (rilpivirine) / J&J
Journal: Rilpivirine as a potential candidate for the treatment of HIV-associated neurocognitive disorders (HAND). (Pubmed Central) - Jan 8, 2020
This study has shown that RPV has an excellent blood-brain barrier penetrability. Thus, in combination with other antiretroviral drugs, better central nervous system (CNS) protection against HAND can possibly be achieved.
- | Edurant (rilpivirine) / J&J
Trial completion date: RISE: A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (clinicaltrials.gov) - Dec 25, 2019
P3, N=100, Recruiting, Sponsor: Johnson & Johnson Pte Ltd
Thus, in combination with other antiretroviral drugs, better central nervous system (CNS) protection against HAND can possibly be achieved. Trial completion date: Feb 2021 --> Dec 2021
- ||| cabotegravir (GSK1265744) / ViiV Healthcare, Edurant (rilpivirine) / J&J
Breaking news 🔊🔥GlaxoSmithKline's HIV drugs division ViiV Healthcare said on Saturday that the @US_FDA U.S. declined to approve its long acting HIV injection cabotegravir and rilpivirine. @PaulSaxMD @CarlosdelRio7 #IDTwitter https://t.co/BKanPdRucJ (Twitter) - Dec 21, 2019
- ||| cabotegravir (GSK1265744) / ViiV Healthcare, Edurant (rilpivirine) / J&J
FDA event: FDA Declines to Approve Cabotegravir/Rilpivirine @Contagion_Live https://t.co/RMtrCqK7P5 (Twitter) - Dec 21, 2019
- | Journal: The inhibitory effect of antiretroviral drugs on the L-carnitine uptake in human placenta. (Pubmed Central) - Dec 20, 2019
Ritonavir, saquinavir and elvitegravir showed the highest inhibitory potential which was further confirmed for ritonavir and saquinavir in placental fresh villous fragments. Our data indicate possible impairment in placental and fetal supply of l-carnitine with ritonavir and saquinavir, while suggesting retained placental carnitine transport with the other antiretroviral drugs.
- ||||| cabotegravir (GSK1265744) / ViiV Healthcare, Edurant (rilpivirine) / J&J, islatravir (MK-8591) / Merck (MSD)
Clinical: Is #pharma doing enough R&D for #HIV meds? Currently there are 3 clinical candidates which could notably change the administration of meds from daily to monthly: injectable cabotegravir/rilpivirine (@ViiVHC @JNJNews), cabotegravir and oral islatravir (@Merck) #WorldAIDSDay (Twitter) - Dec 1, 2019
- || Edurant (rilpivirine) / J&J, Isentress (raltegravir) / Merck (MSD)
Clinical, Observational data, Journal: The Influence of Antiretroviral Therapy on Hepatitis C Virus Viral Load and Liver Fibrosis in Human Immunodeficiency Virus-Coinfected Patients: An Observational Study. (Pubmed Central) - Nov 28, 2019
Our data indicate possible impairment in placental and fetal supply of l-carnitine with ritonavir and saquinavir, while suggesting retained placental carnitine transport with the other antiretroviral drugs. The start and the suspension of ART significantly interferes with HCV-VL in HIV/HCV-coinfected patients.
- || Edurant (rilpivirine) / J&J
Trial primary completion date: A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years (clinicaltrials.gov) - Nov 20, 2019
P2, N=61, Recruiting, Sponsor: Janssen Sciences Ireland UC
The start and the suspension of ART significantly interferes with HCV-VL in HIV/HCV-coinfected patients. Trial primary completion date: Jan 2020 --> Aug 2022
- | Edurant (rilpivirine) / J&J
Trial primary completion date: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - Oct 31, 2019
P3, N=478, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial primary completion date: Jan 2020 --> Aug 2022 Trial primary completion date: Dec 2019 --> Dec 2020
- | Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: Effect on HIV Medications on EPC Cells (clinicaltrials.gov) - Oct 8, 2019
P=N/A, N=30, Recruiting, Sponsor: Sabyasachi Sen
Trial primary completion date: Dec 2019 --> Dec 2020 Trial completion date: Sep 2019 --> Sep 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- | Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J
New P4 trial: PROBE2: RPV+DRV/Cobi Dual Therapy in Subjects With HIV Controlled Infection (clinicaltrials.gov) - Aug 21, 2019
P4, N=1609, Active, not recruiting, Sponsor: A.O. Ospedale Papa Giovanni XXIII
- | Edurant (rilpivirine) / J&J
Enrollment open: A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed (clinicaltrials.gov) - Aug 5, 2019
P2, N=30, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Sep 2019 --> Sep 2020 | Trial primary completion date: Jun 2019 --> Jun 2020 Not yet recruiting --> Recruiting
- | Edurant (rilpivirine) / J&J
Enrollment status: Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine (clinicaltrials.gov) - Jul 24, 2019
P4, N=28, Enrolling by invitation, Sponsor: Chiang Mai University
Not yet recruiting --> Recruiting Recruiting --> Enrolling by invitation
- | Vocabria (cabotegravir oral) / ViiV Healthcare
Trial completion: Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine (clinicaltrials.gov) - Jul 17, 2019
P2b, N=244, Completed, Sponsor: ViiV Healthcare
Recruiting --> Enrolling by invitation Active, not recruiting --> Completed
- | Edurant (rilpivirine) / J&J
New P2 trial: A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed (clinicaltrials.gov) - Jul 8, 2019
P2, N=30, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Trial completion: STEREOS: Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression (clinicaltrials.gov) - May 7, 2019
P=N/A, N=246, Completed, Sponsor: Mahidol University
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Edurant (rilpivirine) / J&J
Trial completion date: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - Apr 20, 2019
P3, N=478, Active, not recruiting, Sponsor: Janssen R&D Ireland
Active, not recruiting --> Completed Trial completion date: Dec 2019 --> Dec 2020
- ritonavir / Generic mfg.
Primary genotype testing and antiretroviral-resistant mutations among people living with HIV () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_1104;
PIs continue to be an option for ART initiation. Primary genotype testing should be enhanced to guide therapy for treatment-naïve people living with HIV and detect potential emerging resistance, especially if low adherence to medications is expected.
- | Nexplanon (etonogestrel implant) / Organon, Edurant (rilpivirine) / J&J
Enrollment open: DRIVE-1: Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant (clinicaltrials.gov) - Mar 28, 2019
P2, N=60, Recruiting, Sponsor: Makerere University
Primary genotype testing should be enhanced to guide therapy for treatment-naïve people living with HIV and detect potential emerging resistance, especially if low adherence to medications is expected. Not yet recruiting --> Recruiting
- | Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment open: More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (clinicaltrials.gov) - Mar 25, 2019
P1/2, N=155, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Edurant (rilpivirine) / J&J
Trial completion date: RISE: A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (clinicaltrials.gov) - Mar 20, 2019
P3, N=100, Recruiting, Sponsor: Johnson & Johnson Pte Ltd
Not yet recruiting --> Recruiting Trial completion date: Aug 2020 --> Dec 2020
- | Edurant (rilpivirine) / J&J
Trial primary completion date: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - Feb 8, 2019
P3, N=478, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial completion date: Aug 2020 --> Dec 2020 Trial primary completion date: Dec 2018 --> Dec 2019
- | Edurant (rilpivirine) / J&J
Trial completion, Trial completion date, Trial primary completion date: DRV/r + RPV QD: Efficacy and Toxicity Reduction (clinicaltrials.gov) - Jan 15, 2019
P3, N=132, Completed, Sponsor: ASST Fatebenefratelli Sacco
Trial primary completion date: Dec 2018 --> Dec 2019 Recruiting --> Completed | Trial completion date: Oct 2017 --> Dec 2018 | Trial primary completion date: Sep 2017 --> Dec 2018
- | Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial completion date, Trial suspension, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Jan 14, 2019
P=N/A, N=400, Suspended, Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Recruiting --> Completed | Trial completion date: Oct 2017 --> Dec 2018 | Trial primary completion date: Sep 2017 --> Dec 2018 Trial completion date: Feb 2020 --> Jun 2020 | Not yet recruiting --> Suspended
- | Edurant (rilpivirine) / J&J
Trial completion date: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - Dec 26, 2018
P3, N=478, Active, not recruiting, Sponsor: Janssen R&D Ireland
Trial completion date: Feb 2020 --> Jun 2020 | Not yet recruiting --> Suspended Trial completion date: Dec 2021 --> Dec 2019
- | Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
New trial: Effect on HIV Medications on EPC Cells (clinicaltrials.gov) - Dec 20, 2018
P, N=30, Recruiting, Sponsor: Sabyasachi Sen
- |||| Prezcobix (darunavir/cobicistat) / Gilead, J&J, Tivicay (dolutegravir) / ViiV Healthcare
New P4 trial: EFFICACY AND SAFETY OF A SIMPLIFICATION TREATMENT BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS USUAL TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS WITH MULTIDRUG RESISTANCE. Eficacia y seguridad de Dolutegravir m (EUDRACT) - Dec 4, 2018
P4, N=100, Ongoing, Sponsor: FUNDACI
- | Trial completion: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Dec 4, 2018
P3, N=224, Completed, Sponsor: University Hospital, Tours
Trial completion date: Dec 2021 --> Dec 2019 Active, not recruiting --> Completed
- | Edurant (rilpivirine) / J&J
Enrollment open: RISE: A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (clinicaltrials.gov) - Oct 16, 2018
P3, N=100, Recruiting, Sponsor: Johnson & Johnson Pte Ltd
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | Edurant (rilpivirine) / J&J
Trial completion date: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - Oct 10, 2018
P3, N=482, Active, not recruiting, Sponsor: Janssen R&D Ireland
Not yet recruiting --> Recruiting Trial completion date: Jun 2019 --> Dec 2021
- | Edurant (rilpivirine) / J&J
Enrollment open: DRIVE-2: Darunavir and Rilpivirine Interactions With Levonorgestrel Implant (clinicaltrials.gov) - Sep 13, 2018
P2, N=60, Recruiting, Sponsor: Makerere University
Trial completion date: Jun 2019 --> Dec 2021 Not yet recruiting --> Recruiting
- | Edurant (rilpivirine) / J&J
New trial: Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients (clinicaltrials.gov) - Sep 9, 2018
P=N/A, N=106, Completed, Sponsor: Mahidol University
- | Edurant (rilpivirine) / J&J
Trial completion date: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1 (clinicaltrials.gov) - Aug 15, 2018
P3, N=482, Active, not recruiting, Sponsor: Janssen R&D Ireland
Not yet recruiting --> Recruiting Trial completion date: Dec 2018 --> Jun 2019
- | Edurant (rilpivirine) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial initiation date: More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (clinicaltrials.gov) - Aug 13, 2018
P1/2, N=155, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial completion date: Dec 2018 --> Jun 2019 Initiation date: Jul 2018 --> Nov 2018
- | Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Trial initiation date, Trial primary completion date, Adverse events: Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting (clinicaltrials.gov) - Aug 9, 2018
P=N/A, N=400, Not yet recruiting, Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Initiation date: Jul 2018 --> Nov 2018 Trial primary completion date: Feb 2018 --> Oct 2018 | Initiation date: Feb 2018 --> Oct 2018
- | Edurant (rilpivirine) / J&J
Trial completion: A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants (clinicaltrials.gov) - Aug 9, 2018
P1, N=110, Completed, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Feb 2018 --> Oct 2018 | Initiation date: Feb 2018 --> Oct 2018 Recruiting --> Completed
- | Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J
Enrollment change: Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis (clinicaltrials.gov) - Jul 26, 2018
P2, N=136, Completed, Sponsor: PATH
Recruiting --> Completed N=104 --> 136