Clinical trials: Pre-exposure Prophylaxis
HIV, HIV Pre-exposure Prophylaxis
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1)…
- Trial name
- NCT06045507
- Testing
- MK-8527
- Where
- 18 sites in United States, Israel and 1 more
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
COVID-19, Viral Respiratory Illnesses
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2…
- Trial name
- NCT04359680
- Testing
- Nitazoxanide, Vitamin Super B-Complex
- Where
- 26 sites in United States
- Volunteers
- 1,407 people
- Sponsor
- Romark Laboratories L.C.
COVID-19
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.
- Trial name
- PROVENT (NCT04625725)
- Testing
- AZD7442
- Where
- 89 sites in United States, Belgium and 3 more
- Volunteers
- 5,197 people
- Sponsor
- AstraZeneca
Hepatitis B
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
- Trial name
- NCT00291941
- Testing
- Henogen HBV vaccine, FENDRIX
- Where
- 24 sites in Belgium, Czechia and 1 more
- Volunteers
- 300 people
- Sponsor
- Henogen
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hiv
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages.
- Trial name
- NCT04233931
- Testing
- PrEP medication adherence mobile app
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR C19 IL (NCT05712096)
- Testing
- EVUSHELD
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- AstraZeneca
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection better than a…
- Trial name
- NCT07071623
- Testing
- MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF)
- Where
- 30 sites in Kenya, South Africa and 1 more
- Volunteers
- 4,580 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pre-Exposure Prophylaxis of HIV Infection
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in…
- Trial name
- PURPOSE 3 (NCT06101329)
- Testing
- Lenacapavir Tablet, Lenacapavir Injection, Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
- Where
- 11 sites in United States
- Volunteers
- 253 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55.
- Trial name
- NCT06943378
- Testing
- Monoclonal antibody JST-010
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Just-Evotec Biologics
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness at UPMC
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR-C19 UPMC (NCT05667116)
- Testing
- EVUSHELD
- Where
- United States
- Volunteers
- 4,232 people
- Sponsor
- AstraZeneca
Rabies
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen
To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the…
- Trial name
- NCT07055295
- Testing
- Rabies Vaccine (Serum-free Vero Cell), Freeze-dried, Verorab®
- Where
- Pakistan
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Pre-Exposure Prophylaxis of HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or…
- Trial name
- DISCOVER (NCT02842086)
- Testing
- F/TAF, F/TDF
- Where
- 93 sites in United States, Austria and 9 more
- Volunteers
- 5,399 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
eVusheld Assessment reaL wORld Effectiveness in DoD Health System
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR DoD (NCT05569408)
- Testing
- EVUSHELD
- Where
- United States
- Volunteers
- 4,724 people
- Sponsor
- AstraZeneca
Coronavirus Disease 2019 (COVID-19)
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination…
- Trial name
- ENDURE (NCT05375760)
- Testing
- AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])
- Where
- 16 sites in United States
- Volunteers
- 251 people
- Sponsor
- AstraZeneca
Healthy, HIV Pre-exposure Prophylaxis
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.
- Trial name
- NCT06580587
- Testing
- MK-8527
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
COVID-19, SARS-CoV-2
Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
- Trial name
- NOVELLA (NCT06057064)
- Testing
- Biological: AZD3152
- Where
- 6 sites in Russia
- Volunteers
- 116 people
- Sponsor
- AstraZeneca
COVID-19
An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
- Trial name
- Evusheld DBR (NCT06156982)
- Testing
- Evusheld
- Where
- Japan
- Volunteers
- 397 people
- Sponsor
- AstraZeneca