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Active, Not Recruiting

NCT Number: NCT04776252

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)

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) [DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Holdsworth House Medical Practice ( Site 0700), Darlinghurst, New South Wales, Australia

Loading trial locations.

About this study

As of Amendment 12, participants will have the option to continue receiving DOR/ISL (100 mg/0.75 mg) until treatment alternatives are identified, or up to Week 288 given that participants are still deriving benefit, based on individual benefit/risk assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
  • Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
  • Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)

Exclusion criteria

  • Is taking or is anticipated to require any prohibited therapies.

Treatment and study plan

MK-8591A

Drug

FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks

Primary outcomes

  1. Participants with serious adverse events (SAEs)

    Time frame: Up to Week 198

    Percentage of participants with serious adverse events (SAEs)

  2. Participants who discontinued due to an adverse event (AE)

    Time frame: Up to Week 192

    Percentage of participants who discontinued study treatment due to an AE.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Mar 1, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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