HIV Preexposure Prophylaxis Clinical Trial
— Impower-024Official title:
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection
| Verified date | August 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.
| Status | Completed |
| Enrollment | 494 |
| Est. completion date | August 4, 2023 |
| Est. primary completion date | August 4, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 16 Years and older |
| Eligibility | Inclusion Criteria: - Has confirmed Human Immunodeficiency Virus (HIV) uninfected based on negative HIV-1/HIV-2 test result before randomization - Is sexually active with male or transgender women (TGW) partners defined as having anal sexual intercourse with a man or TGW at least once in the past month - Is at high risk for sexually acquiring HIV-1 infection based on self-report of at least 1 of the following: a) Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship b) More than 5 partners (anal intercourse) in the 6 months prior to screening c) Any unprescribed stimulant drug use in the 6 months prior to screening d) Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening - Participants 16 or 17 years of age must weigh =35 kg. Enrollment for 16- to 17-year-old participants will begin only after completion of the Sentinel Cohort IA and review of IA results by the external data monitoring committee (eDMC) - Has no plans to relocate or travel away from the site for =4 consecutive weeks during study participation Exclusion Criteria: - Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator - Has chronic HBV infection or past HBV infection which could indicate risk for Hepatitis B reactivation - Has known current or chronic history of liver disease or known hepatic or biliary abnormalities, unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction - Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer or in situ anal cancers - Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance 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, such that it is not in the best interest of the participant to enroll - Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time - Is currently receiving or is anticipated to require any prohibited therapies outlined in the study from 30 days prior to Day 1 through the duration of the study - Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device, within 30 days prior to Day 1 through the duration of the study - Has exclusionary laboratory values within 45 days prior to Day 1 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Centro de Referência e Treinamento DST/AIDS ( Site 0351) | Sao Paulo | |
| France | Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151) | Paris | Ile-de-France |
| Japan | Center Hospital of the National Center for Global Health and Medicine ( Site 0101) | Shinjyuku-ku | Tokyo |
| Peru | Via Libre ( Site 0404) | Lima | |
| South Africa | Desmond Tutu HIV Foundation ( Site 0202) | Cape Town | Western Cape |
| South Africa | Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203) | Johannesburg | Gauteng |
| South Africa | Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201) | Johannesburg | Gauteng |
| Thailand | Chulalongkorn University-Pediatrics ( Site 0051) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | HIV Netherlands Australia Thailand Research Collaboration ( Site 0056) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052 | Chiang Mai | |
| United States | Ponce De Leon Center Grady Health ( Site 0032) | Atlanta | Georgia |
| United States | Central Texas Clinical Research ( Site 0002) | Austin | Texas |
| United States | University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007) | Birmingham | Alabama |
| United States | The University of North Carolina at Chapel Hill ( Site 0019) | Chapel Hill | North Carolina |
| United States | Howard Brown Health Center ( Site 0004) | Chicago | Illinois |
| United States | Midway Immunology and Research Center ( Site 0014) | Fort Pierce | Florida |
| United States | The Crofoot Research Center ( Site 0025) | Houston | Texas |
| United States | The University of Mississippi Medical Center ( Site 0012) | Jackson | Mississippi |
| United States | Global Research Institute ( Site 0031) | Los Angeles | California |
| United States | UCLA Center for Clinical AIDS Research and Education ( Site 0011) | Los Angeles | California |
| United States | University of Miami Miller School of Medicine-Infectious Disease ( Site 0029) | Miami | Florida |
| United States | Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017) | Newark | New Jersey |
| United States | Orlando Immunology Center ( Site 0010) | Orlando | Florida |
| United States | Bridge HIV - San Francisco Department of Public Health ( Site 0003) | San Francisco | California |
| United States | The GW Medical Faculty Associates-Medicine ( Site 0033) | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Brazil, France, Japan, Peru, South Africa, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE will be reported for each treatment arm. | Up to approximately 26 months | |
| Primary | Percentage of Participants Who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE will be reported for each treatment arm. | Up to approximately 24 months | |
| Secondary | Incidence Rate Per Year of Confirmed HIV-1 infection Among Participants | Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status. The secondary incidence analysis to compare the incidence rate per year of confirmed HIV-1 Infections between the ISL QM arm and the FTC/TDF or FTC/TAF QD arm participants. HIV serology tests and PCR tests will be done at pre-specified timepoints to confirm HIV-1 infection. | Up to approximately 24 months |
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