Islatravir and Ulonivirine for HIV-1 Treatment
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Recruiting
Phase 2
Phase 3
Interventional Study
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 570 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for people who are HIV-1 positive and have not received any treatment before. Participants will take a combination of two medicines once a week to see how well they work compared to the usual HIV-1 treatment.
Are You a Good Fit for This Trial?
You may be able to join if
- I am HIV-1 positive.
- I have at least 500 copies of HIV-1 in my blood.
- I have a CD4+ T-cell count of at least 200 cells/mm³.
- I have never taken any antiretroviral therapy (ART) before.
You may not be able to join if
- I have HIV-2.
- I have an active AIDS-related opportunistic infection.
- I have active hepatitis C or B virus infection.
- I have had cancer in the last 5 years, except for certain skin cancers.
- I have taken islatravir or ulonivirine in the past.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers w…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
* Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
* Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥2…
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