Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03272347 · ClinicalTrials.gov registry record · Phase 2
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
A Phase 2 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT03272347: Completed Phase 2 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
NCT03272347 is a Phase 2 study of HIV-1-infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 123 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03272347, a Phase 2 study of HIV-1-infection, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.
Primary Outcome
Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.
Conditions Studied
Interventions
- DRUG Doravirine
- DRUG Lamivudine
- DRUG Islatravir
- DRUG Placebo to Islatravir
- DRUG Placebo to Doravirine
Study Locations (20)
Other
- Biomedica Research Group ( Site 0202) - Santiago
- Hospital Dr. Hernan Henriquez Aravena ( Site 0203) - Temuco
- Hopital Avicenne ( Site 2302) - Bobigny
- Hopital Saint-Andre ( Site 2307) - Bordeaux
- CHU Hotel Dieu ( Site 2308) - Nantes
- CHU de Nice Hopital Archet 1 ( Site 2303) - Nice
- Hopital Bichat - Claude Bernard ( Site 2309) - Paris
- Hopital Pitie Salpetriere ( Site 2305) - Paris
- Hopital Saint Louis ( Site 2306) - Paris
Texas
- Saint Hope Foundation, Inc. ( Site 0116) - Bellaire
- North Texas Infectious Diseases Consultants, PA ( Site 0103) - Dallas
- Tarrant County Infectious Disease Associates ( Site 0112) - Fort Worth
- The Crofoot Research Center, Inc. ( Site 0118) - Houston
Arizona
- Pueblo Family Physicians ( Site 0119) - Phoenix
California
- University California / Davis ( Site 0101) - Sacramento
District of Columbia
- Whitman Walker Clinic ( Site 0108) - Washington D.C.
Florida
- Orlando Immunology Center (OIC) ( Site 0105) - Orlando
Illinois
- Northstar Medical Center ( Site 0102) - Chicago
Missouri
- Kansas City CARE Clinic ( Site 0106) - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 2 |
What the finished NCT03272347 record still lists
NCT03272347 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (65% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which Doravirine is the first listed.
NCT03272347 names 20 study sites across 9 states, led by Other, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT03272347 about?
NCT03272347 is a clinical study titled "Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)". This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HI...
What is the current status of trial NCT03272347?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2017-11-27. Estimated completion is 2022-03-09.
What conditions does trial NCT03272347 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT03272347?
The interventions under investigation include: Doravirine (DRUG), Lamivudine (DRUG), Islatravir (DRUG), Placebo to Islatravir (DRUG), Placebo to Doravirine (DRUG).
Who is sponsoring clinical trial NCT03272347?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03272347 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03272347's enrollment target sits among peer trials
123 27th of 71 higher than 45 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Improving Coronary Vascular Health in Women
RECRUITING · Phase 2
-
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
RECRUITING · Phase 2
-
PrEPsmart 2-1-1 Pilot
RECRUITING · Phase 2
-
A Clinical Trial of STP0404 in Adults With HIV-1 Infection
RECRUITING · Phase 2
-
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
RECRUITING · Phase 2
-
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05285891 · 123 participants · Phase 4
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
- NCT05334368 · 123 participants · Phase 3
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
- NCT06088355 · 123 participants · NA
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
- NCT06111131 · 123 participants · NA
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI