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NCT04644029 · ClinicalTrials.gov registry record · Phase 3
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 3
- Development phase
- 730
- Enrollment target
NCT04644029 is a Phase 3 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 730 participants.
The verdict
NCT04644029, a Phase 3 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 730 participants
- Enrollment target
Study Summary
This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.
Interventions
- DRUG FTC/TDF
- DRUG Placebo to FTC/TDF
- DRUG Islatravir
- DRUG Placebo to ISL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2024-06-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04644029
The ClinicalTrials.gov registry entry for NCT04644029 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 730 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which FTC/TDF is the first listed.
NCT04644029 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04644029 about?
NCT04644029 is a clinical study titled "Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)". This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, em...
What is the current status of trial NCT04644029?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 730 participants. The study started on 2021-02-24. Estimated completion is 2024-06-11.
What interventions are being tested in trial NCT04644029?
The interventions under investigation include: FTC/TDF (DRUG), Placebo to FTC/TDF (DRUG), Islatravir (DRUG), Placebo to ISL (DRUG).
Who is sponsoring clinical trial NCT04644029?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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