Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04223778) enrolled 336 people with HIV in each of two groups — a total of 672 participants. One group switched to a combination of two medicines called doravirine and islatravir (DOR/ISL) straight away, while the other group stayed on their existing HIV treatment for the first 48 weeks before also switching to DOR/ISL. The trial was measuring the level of HIV in participants' blood (called HIV-1 RNA, a way of counting virus particles), as well as tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that at the 48-week mark, 0.0% of participants in the DOR/ISL group had a detectable HIV virus level of 50 copies per millilitre of blood or more, compared with 1.5% in the group that stayed on their existing treatment. Looking at those with virus levels *below* the detectable threshold (under 50 copies/mL), the reported figures were 95.2% for the DOR/ISL group and 94.3% for the continuing-treatment group. By week 96, the reported data shows that 1.2% of the original DOR/ISL group had virus levels at or above 50 copies/mL, with 85.7% below 50 copies/mL; for the group that switched over later, 0.9% were above 50 copies/mL at week 96, with 89.6% below 50 copies/mL. Regarding unwanted medical events up to week 48, 80.1% of the DOR/ISL group reported at least one such event, compared with 70.2% in the continuing-treatment group. The reported data also shows that 2.1% of the DOR/ISL group stopped taking the study medicine because of an adverse event, versus 0.3% in the continuing-treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38734015) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 HIV and AIDS Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are HIV-1 positive
- You have been taking a stable, daily oral HIV treatment (either 2 or 3 medications, with or without a booster) for at least 3 months before signing up, and your HIV levels in the blood have been undetectable (very low) during that time
- You have never had a treatment failure where your HIV levels became detectable again on any HIV medication you have taken
- If you are a woman, you are eligible if you are not pregnant or breastfeeding, AND you either cannot get pregnant, are using an accepted form of birth control, or are not having heterosexual sex as a regular lifestyle choice — and you must have a negative pregnancy test within 24 hours before starting the study medication
Who may not be able to join:
- You have HIV-2 (a different type of HIV) rather than, or in addition to, HIV-1
- You have a known allergy or medical reason that prevents you from taking any of the medications used in this trial
- You currently have active hepatitis (liver inflammation) from any cause, including an active Hepatitis B infection alongside your HIV
- You have had a cancer diagnosis in the last 5 years — with some exceptions for certain minor skin cancers or early-stage cervical cancer (confirm with trial site)
- You are currently taking, or expect to need, medications that suppress or alter your immune system, or any other medications not allowed by the trial
- You are currently taking the long-acting injectable HIV treatment cabotegravir-rilpivirine
- You have taken part in another clinical trial involving an experimental drug or device within the last 45 days, or plan to during this study
- Your HIV has been shown to be resistant to a drug called doravirine
- You plan to become pregnant or donate eggs at any point during the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Director, Merck Sharp & Dohme LLC
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48; Percentage of Participants With One or More Adverse Events (AEs) up to Week 48; Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.