Clinical trials: Pre-Exposure Prophylaxis of HIV Infection
HIV Prevention
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM…
- Trial name
- PATH-PrEP (NCT01781806)
- Testing
- emtricitabine 200mg/tenofovir 300mg
- Where
- 2 sites in United States
- Volunteers
- 328 people
- Sponsor
- University of California, Los Angeles
HIV-1 Infections, HIV Infections
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
- Trial name
- Partners PrEP (NCT00557245)
- Testing
- Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
- Where
- 9 sites in Kenya, Uganda
- Volunteers
- 4,758 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Prevention
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
- Trial name
- NCT04558554
- Testing
- pharmacy-based PrEP delivery
- Where
- 2 sites in Kenya
- Volunteers
- 1,216 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs).
- Trial name
- NCT00119106
- Testing
- Tenofovir disoproxil
- Where
- Thailand
- Volunteers
- 2,413 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
HIV, Prophylaxis
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW
This is a research study to determine the best way to dose Truvada®, an oral medication licensed to be taken as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, in transgender women who are also taking feminizing…
- Conditions
- HIV, Prophylaxis, Transgender
- Trial name
- NCT04760691
- Testing
- Truvada alone, Truvada plus Leuprolide 11.25mg intramuscular injection, Truvada plus Estradiol 1 mg
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Gonorrhea, Chlamydia
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including…
- Conditions
- Gonorrhea, Chlamydia, Syphilis
- Trial name
- NCT03980223
- Testing
- Doxycycline Hyclate Delayed-Release 200 mg
- Where
- 3 sites in United States
- Volunteers
- 641 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
HIV Infections
Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV.
- Trial name
- NCT02213328
- Testing
- Truvada
- Where
- 2 sites in South Africa
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv
PK of TAF and TDF for PrEP in Pregnant and Postpartum Women
This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum.
- Trial name
- PrEP-PP PK (NCT04937881)
- Testing
- Tenofovir alafenamide, Tenofovir Disoproxil Fumarate
- Where
- South Africa
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV…
- Trial name
- NCT04692077
- Testing
- Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
- Where
- 4 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate…
- Trial name
- NCT01632995
- Testing
- FTC 200 mg/TDF 300 mg fixed-dose combination tablet
- Where
- 3 sites in United States
- Volunteers
- 557 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sexually Transmitted Diseases
A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex…
- Trial name
- PReGo (NCT03881007)
- Testing
- Mouthwash with LCM
- Where
- Belgium
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
HIV Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU).
- Trial name
- NCT01772823
- Testing
- 3MV, PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 12 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
- Trial name
- NCT02720094
- Testing
- Cabotegravir Oral Tablet, TDF/FTC tablets, CAB LA
- Where
- 43 sites in United States, Argentina and 5 more
- Volunteers
- 4,570 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial
Alignment of PrEP Use With HIV Risk in Young Women and Men
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs.
- Conditions
- Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial, HIV Infections
- Trial name
- NCT04664998
- Testing
- Daily oral PrEP
- Where
- Uganda
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- ADAPT (NCT01327651)
- Testing
- Daily dosing, Time-driven dosing, Event-driven dosing
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Treatment Adherence and Compliance
PrEP iT! Mobile App Intervention
The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM).
- Trial name
- PrEP iT! (NCT04509076)
- Testing
- PrEP iT! (plus usual PrEP care), Usual PrEP care
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- San Diego State University
Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission
The OPENS Trial: Offering Women PrEP (Aim 2)
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel…
- Conditions
- Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
- Trial name
- NCT05619497
- Testing
- Clinic-wide Trainings, Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)
- Where
- United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco