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- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Mar 24, 2021
P3, N=680, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Mar 2024 --> Nov 2023 | Trial primary completion date: Mar 2024 --> Nov 2023
- doravirine/islatravir (MK-8591A) / Merck (MSD)
[VIRTUAL] WEEK 96 ANALYSIS OF VIRAL BLIPS FROM A PHASE 2B TRIAL OF ISLATRAVIR AND DORAVIRINE () - Mar 18, 2021 - Abstract #CROI2021CROI_625;
In a Phase 2b trial in treatment-naïve adults with HIV-1, participants were randomized to receive ISL (0.25, 0.75 or 2.25 mg) + DOR (100 mg) and lamivudine (3TC, 300 mg) QD, or a fixed-dose combination of DOR, 3TC and tenofovir disoproxil fumarate (DOR/3TC/TDF)... Viral blips were relatively rare for all treatment groups and were not associated with a loss of virologic suppression or PDVF.
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial primary completion date: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (clinicaltrials.gov) - Mar 9, 2021
P3, N=100, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Viral blips were relatively rare for all treatment groups and were not associated with a loss of virologic suppression or PDVF. Trial primary completion date: Aug 2025 --> Jul 2024
- |||||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) (clinicaltrials.gov) - Feb 28, 2021
P3, N=2000, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (clinicaltrials.gov) - Dec 19, 2020
P3, N=100, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Aug 2025 --> Jul 2024 Trial completion date: Apr 2022 --> Aug 2025 | Trial primary completion date: Apr 2022 --> Aug 2025
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Nov 9, 2020
P2, N=45, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Apr 2022 --> Aug 2025 | Trial primary completion date: Apr 2022 --> Aug 2025 Not yet recruiting --> Recruiting
- |||| doravirine/islatravir (MK-8591A) / Merck (MSD)
P2 data, P3 data: 96W phase 2 results for islatravir + doravirine dual ART: viral suppression & PDVF from @jmmolinaparis #HIVGlasgow none met criteria for resistance testing & 5/7 PDVF had baseline VL >100k - one of the combinations I'm most eager to see phase 3 data for (Twitter) - Oct 8, 2020
- doravirine/islatravir (MK-8591A) / Merck (MSD)
[VIRTUAL] Renal safety through 96 weeks from a phase II trial (P011) of islatravir and doravirine in treatment‐naïve adults with HIV‐1 () - Sep 21, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_204;
This exploratory analysis of a small phase II trial did not find a dose‐response relationship for ISL or clinically meaningful changes in serum creatinine or eGFR with DOR+ISL or DOR/3TC/TDF. Renal safety will be further examined in the DOR+ISL phase III program.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
[VIRTUAL] Analysis of protocol‐defined virologic failure through 96 weeks from a phase II trial (P011) of islatravir and doravirine in treatment‐naïve adults with HIV‐1 () - Sep 21, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_203;
Rates of PDVF were low and all participants who discontinued due to PDVF had HIV‐1 RNA levels below the clinically significant level of 200 copies/mL. Only one additional PDVF occurred between Week 48 and Week 96.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment change: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Sep 11, 2020
P2, N=45, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
Only one additional PDVF occurred between Week 48 and Week 96. N=30 --> 45
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - Aug 30, 2020
P3, N=578, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=30 --> 45 Recruiting --> Active, not recruiting
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (clinicaltrials.gov) - Aug 24, 2020
P3, N=578, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- [VIRTUAL] Analysis of protocol defined virologic failure through week 48 from a phase 2 trial (P011) of islatravir and doravirine in treatment-na€ıve adults with HIV-1 infection (Abstract Sessions On-Demand Channel) - Jun 22, 2020 - Abstract #AIDS2020AIDS_1494;
The observed low-level viraemia was comparable to levels detected in other treatment-na€ıve studies. HIV-1 RNA levels Over Time for Participants with PDVF.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial initiation date, Trial primary completion date: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - May 18, 2020
P2, N=30, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
HIV-1 RNA levels Over Time for Participants with PDVF. Trial completion date: Apr 2022 --> Nov 2023 | Initiation date: Jun 2020 --> Nov 2020 | Trial primary completion date: Oct 2021 --> May 2022
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (clinicaltrials.gov) - Mar 25, 2020
P3, N=100, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Apr 2022 --> Nov 2023 | Initiation date: Jun 2020 --> Nov 2020 | Trial primary completion date: Oct 2021 --> May 2022 Not yet recruiting --> Recruiting
- | islatravir (MK-8591) / Merck (MSD)
Trial completion date: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Mar 20, 2020
P2b, N=123, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial completion date: Apr 2021 --> Mar 2022
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Mar 10, 2020
P3, N=680, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Apr 2021 --> Mar 2022 Not yet recruiting --> Recruiting
- | Idvynso (doravirine/islatravir) / Merck (MSD)
New P2 trial: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Mar 4, 2020
P2, N=30, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (clinicaltrials.gov) - Feb 27, 2020
P3, N=578, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - Feb 27, 2020
P3, N=578, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Trial primary completion date: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (clinicaltrials.gov) - Feb 7, 2020
P3, N=578, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial primary completion date: May 2021 --> Oct 2021
- | Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (clinicaltrials.gov) - Jan 18, 2020
P3, N=100, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Jan 18, 2020
P3, N=680, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (clinicaltrials.gov) - Jan 8, 2020
P3, N=578, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - Jan 8, 2020
P3, N=578, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | islatravir (MK-8591) / Merck (MSD)
Trial completion date, Trial primary completion date: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Oct 17, 2019
P2b, N=120, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: May 2021 --> Oct 2021 Trial completion date: Oct 2020 --> Apr 2021 | Trial primary completion date: Oct 2020 --> Apr 2021
- | islatravir (MK-8591) / Merck (MSD)
Trial primary completion date: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Apr 16, 2019
P2b, N=120, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Oct 2020 --> Apr 2021 | Trial primary completion date: Oct 2020 --> Apr 2021 Trial primary completion date: Apr 2019 --> Oct 2020
- ||| islatravir (MK-8591) / Merck (MSD)
Enrollment closed: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Apr 26, 2018
P2b, N=120, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Apr 2019 --> Oct 2020 Recruiting --> Active, not recruiting
- |||| islatravir (MK-8591) / Merck (MSD)
Enrollment open: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Dec 12, 2017
P2b, N=120, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||| islatravir (MK-8591) / Merck (MSD)
New P2b trial: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Sep 4, 2017
P2b, N=120, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.