BridgeMD
Dose Ranging, Switch Study of ISL and MK‑8507 Once-Weekly
EU CTIS ID: 2024-511041-19-00
What this study is testing
To evaluate the safety and tolerability of ISL + MK-8507 once-weekly as assessed by review of the accumulated safety data.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
- Has been virologically suppressed on BIC/FTC/TAF for ≥6 months
- Has a screening CD4+ T-cell count >200 cells/mm^3 (completed by the central laboratory)
- Is male or female, at least 18 years of age, at the time of signing the informed consent
- Female participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is not a woman of childbearing potential (WOCBP), or b) is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
You likely can't join if
- Has HIV-2 infection
- Is female and expecting to conceive or donate eggs at any time during the study
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)
- Has a current (active) diagnosis of acute hepatitis due to any cause
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
See the full eligibility criteria
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
- Has been virologically suppressed on BIC/FTC/TAF for ≥6 months
- Has a screening CD4+ T-cell count >200 cells/mm^3 (completed by the central laboratory)
- Is male or female, at least 18 years of age, at the time of signing the informed consent
- Female participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is not a woman of childbearing potential (WOCBP), or b) is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
- Has HIV-2 infection
- Is female and expecting to conceive or donate eggs at any time during the study
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)
- Has a current (active) diagnosis of acute hepatitis due to any cause
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
- Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
- Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Switzerland. 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 EU CTIS; the study team decides eligibility.