Clinical trials: Pre-exposure Prophylaxis (PrEP)
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.
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
A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and…
- Trial name
- NCT01902472
- Where
- United States
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Pre-exposure Prophylaxis for Prevention of HIV Infection
A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
This is a prospective, 3-year observational study to describe drug utilization in uninfected individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP)…
- Trial name
- NCT01865799
- Where
- United States
- Volunteers
- 64,186 people
- Sponsor
- Gilead Sciences
HIV
Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)
This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure…
- Trial name
- NCT01906255
- Where
- United States
- Volunteers
- 10,577 people
- Sponsor
- Gilead Sciences
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
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
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
HIV Infections
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States.
- Trial name
- PROPEL (NCT07473778)
- Testing
- Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF)
- Where
- 44 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF)…
- Trial name
- PURPOSE 5 (NCT06513312)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Where
- 14 sites in France, United Kingdom
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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