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New treatment option for Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Official title A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
ClinicalTrials.gov ID: NCT07266831
What this study is testing
What is ISL?
ISL is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for human immunodeficiency virus type 1 (hiv-1) infection.
Also referred to as islatravir, MK-8591.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 ≥200 cells/mm\^3.
- Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1...
You likely can't join if
- Has human immunodeficiency virus type 2 (HIV-2) infection.
- Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
- Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin...
- Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Ft. Pierce, Florida, United States
- Miami Gardens, Florida, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- West Palm Beach, Florida, United States
- Decatur, Georgia, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Kansas City, Missouri, United States
- Hillsborough, New Jersey, United States
- Charlotte, North Carolina, United States
- Greensboro, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Bellaire, Texas, United States
- Dallas, Texas, United States
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Ft. Pierce, Florida, United States; Miami Gardens, Florida, United States; Orlando, Florida, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.