Clinical trials: Pre-Exposure Prophylaxis
- Condition Pre-Exposure Prophylaxis
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Immunocompromised
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.
- Trial name
- NCT05074433
- Testing
- casirivimab+imdevimab
- Where
- 67 sites in United States, Mexico
- Volunteers
- 66 people
- Sponsor
- Regeneron Pharmaceuticals
COVID-19, SARS-CoV-2
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
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
- SUPERNOVA (NCT05648110)
- Testing
- AZD5156 (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort)
- Where
- 215 sites in United States, Australia and 16 more
- Volunteers
- 3,882 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hiv
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men.
- Trial name
- NCT04633200
- Testing
- DOT mobile app
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
Infection, Human Immunodeficiency Virus
Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)
This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects.
- Trial name
- NCT02076178
- Testing
- 744 Tablet, 744 LA Injection
- Where
- 10 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in…
- Trial name
- PILLAR (NCT05374525)
- Testing
- APRETUDE, Cabotegravir OLI
- Where
- 17 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Virus Diseases, Rabies
A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.
The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM…
- Trial name
- NCT02545517
- Testing
- Rabipur, Blood sampling, Purified Chick-Embryo Cell Rabies Vaccine
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
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
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
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
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare