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- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Scaling a non-human primate physiologically-based pharmacokinetic model of extended-release MK-2048 and combination MK-2048/vicriviroc (MK-2048A) intravaginal rings into humans using phase 1 MTN-027 and MTN-028 studies (Poster Exhibition) - Aug 9, 2024 - Abstract #HIVR4P2024HIVR4P_903;
The model's ability to predict most drug concentrations within a 90% prediction interval highlights its utility in guiding IVR design and dosing optimization for PrEP. Future work includes continued refinement of the PBPK model and extending the model to evaluate other vaginal formulations for PrEP interventions.
- | MK-2048 vaginal film / Merck (MSD)
Trial completion: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - Nov 7, 2022
P1, N=37, Completed, Sponsor: Hillier, Sharon, PhD
Future work includes continued refinement of the PBPK model and extending the model to evaluate other vaginal formulations for PrEP interventions. Active, not recruiting --> Completed
- | MK-2048 vaginal film / Merck (MSD)
Enrollment closed: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - May 25, 2022
P1, N=37, Active, not recruiting, Sponsor: Hillier, Sharon, PhD
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | MK-2048 vaginal film / Merck (MSD)
Preclinical, Journal: Development and Evaluation of Nanoparticles-in-Film Technology to Achieve Extended In Vivo Exposure of MK-2048 for HIV Prevention. (Pubmed Central) - Mar 27, 2022
PNP films showed sustained drug levels for at least 3 weeks in the macaque vaginal fluid. This work demonstrates the synergy of integrating nanomedicine and polymeric film technology to achieve sustained vaginal drug delivery.
- | MK-2048 vaginal film / Merck (MSD)
Trial completion date, Trial primary completion date: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - Feb 3, 2022
P1, N=48, Recruiting, Sponsor: Hillier, Sharon, PhD
This work demonstrates the synergy of integrating nanomedicine and polymeric film technology to achieve sustained vaginal drug delivery. Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Nov 2021 --> Mar 2022
- | MK-2048 vaginal film / Merck (MSD)
Trial primary completion date: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - Oct 24, 2021
P1, N=48, Recruiting, Sponsor: Hillier, Sharon, PhD
Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Nov 2021 --> Mar 2022 Trial primary completion date: Aug 2021 --> Nov 2021
- | MK-2048 vaginal film / Merck (MSD)
Journal: Activation of PERK-ATF4-CHOP pathway as a novel therapeutic approach for efficient elimination of HTLV-1-infected cells. (Pubmed Central) - May 15, 2021
Our findings demonstrated that MK-2048 selectively induces HTLV-1-infected cell apoptosis via the activation of the UPR. This novel regulatory mechanism of the HIV IN inhibitor MK-2048 in HTLV-1-infected cells provides a promising prophylactic and therapeutic target for HTLV-1-related diseases including ATL.
- | MK-2048 vaginal film / Merck (MSD)
Trial primary completion date: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - Apr 28, 2021
P1, N=48, Recruiting, Sponsor: Hillier, Sharon, PhD
This novel regulatory mechanism of the HIV IN inhibitor MK-2048 in HTLV-1-infected cells provides a promising prophylactic and therapeutic target for HTLV-1-related diseases including ATL. Trial primary completion date: May 2021 --> Aug 2021
- | MK-2048 vaginal film / Merck (MSD)
Enrollment open: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - Sep 3, 2020
P1, N=48, Recruiting, Sponsor: Hillier, Sharon, PhD
Trial primary completion date: May 2021 --> Aug 2021 Not yet recruiting --> Recruiting
- || vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Clinical, P1 data, PK/PD data, Journal: Phase 1 Safety and Pharmacokinetics Study of MK-2048/Vicriviroc (MK-4176)/MK-2048A Intravaginal Rings. (Pubmed Central) - May 9, 2020
Tissue-associated VCV and/or MK-2048 did not correlate with inhibition of HIV infection. These data highlight the need to assess adequacy of drug dosing in the VR and measuring genital tissue drug concentrations to develop more precise concentration-response relationships.
- || vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
P1 data, PK/PD data, Journal: Phase 1 Pharmacokinetic Trial of 2 Intravaginal Rings Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048. (Pubmed Central) - May 9, 2020
In this first study evaluating 2 doses of a combination VCV/MK-2048 VR, both rings were found to be safe and well tolerated. VCV and MK-2048 were detectable in plasma, CVF, and cervical tissue samples, and drug release and plasma drug exposure were higher for the original-dose than for the low-dose ring.
- | bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Journal: Integrase Inhibitors: After 10 Years of Experience, Is the Best Yet to Come? (Pubmed Central) - Apr 29, 2020
Since that time, several other INSTIs have been introduced including elvitegravir, dolutegravir, and, most recently, bictegravir, that have shown great utility as part of antiretroviral regimens in both treatment-naive and treatment-experienced patients...After 10 years of experience with INSTIs, newer agents are on the horizon such as cabotegravir and MK-2048 for potential use as either HIV pre-exposure prophylaxis or maintenance therapy. This review provides a brief overview of the INSTI class, including agents currently available and those still in development, reviews available data from both completed and ongoing clinical trials, and outlines simplification strategies using INSTIs.
- | MK-2048 vaginal film / Merck (MSD)
New P1 trial: FAME103: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048 (clinicaltrials.gov) - Mar 24, 2020
P1, N=48, Not yet recruiting, Sponsor: Hillier, Sharon, PhD
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Trial completion: Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048 (clinicaltrials.gov) - May 4, 2016
P1, N=19, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This review provides a brief overview of the INSTI class, including agents currently available and those still in development, reviews available data from both completed and ongoing clinical trials, and outlines simplification strategies using INSTIs. Active, not recruiting --> Completed
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Trial completion: Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048 (clinicaltrials.gov) - Mar 18, 2016
P1, N=48, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Active, not recruiting --> Completed
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Enrollment closed: Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048 (clinicaltrials.gov) - Feb 24, 2016
P1, N=18, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Enrollment closed: Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048 (clinicaltrials.gov) - Feb 17, 2016
P1, N=48, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Enrollment open: Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048 (clinicaltrials.gov) - Jul 20, 2015
P1, N=18, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
Enrollment open: Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048 (clinicaltrials.gov) - Jun 20, 2015
P1, N=48, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
New P1 trial: Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048 (clinicaltrials.gov) - Apr 17, 2015
P1, N=18, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- vicriviroc (MK-7690) / Merck (MSD), MK-2048 vaginal film / Merck (MSD)
New P1 trial: Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048 (clinicaltrials.gov) - Feb 5, 2015
P1, N=48, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)