Clinical trials: Tenofovir
Renal Injury
Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children
The goal of this project is to determine whether and how in utero exposure to Tenofovir affects renal function in HIV-exposed uninfected infants
- Trial name
- NCT04070482
- Testing
- Tenofovir exposure in utero and during breastfeeding
- Where
- 3 sites in Cameroon
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Yaounde 1
HIV/AIDS, HIV Prevention
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche.
- Trial name
- NCT04686279
- Testing
- Tenofovir Douche
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077151
- Testing
- PrEP Demonstration Project
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077138
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
HIV Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.
- Trial name
- NCT03593655
- Testing
- Dapivirine vaginal ring, FTC/TDF
- Where
- 4 sites in South Africa, Uganda and 1 more
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)
Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks.
- Trial name
- NCT03074786
- Testing
- Dapivirine, Truvada
- Where
- South Africa
- Volunteers
- healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
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
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT03652623
- Testing
- TDF/FTC
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
Human Immunodeficiency Virus
Relationship of Tenofovir With HIV-1 Suppression in ex Vivo Tissue in Adolescents
Microbicides are topical medicines that can prevent infection by Human Immunodeficiency Virus (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is becoming infected with HIV all over the world.
- Trial name
- NCT02134431
- Testing
- flexible sigmoidoscopy or colonoscopy with biopsies
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections, Sexually Transmitted Diseases
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner…
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Blood-Borne Infections, Communicable Disease
- Trial name
- NCT05307991
- Testing
- PrEP, STI testing, Assisted partner notification
- Where
- Malawi
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Acceptability of Health Care, Adherence, Medication
Project Engage: Oral PrEP Acceptability
This study is a two-arm open label acceptability study that will examine acceptability of, and adherence to, once daily dosing regimen of F/TDF (Truvada) and an investigational once daily dosing regimen of F/TAF (Descovy) under…
- Trial name
- NCT05458765
- Testing
- emtricitabine/tenofovir alafenamide, Emtricitabine / Tenofovir Disoproxil Oral Tablet
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Bone Demineralization, Hypoestrogenism
The Kampala Women's Bone Study
The primary objective of this study is to address critical safety questions with concurrent TDF-based PrEP and DMPA use. We hypothesize that young women using TDF-based PrEP and DMPA will have lower bone acquisition and altered…
- Conditions
- Bone Demineralization, Hypoestrogenism, Subclinical Kidney Injury, Bone Microarchitecture
- Trial name
- NCT03464266
- Testing
- FTC/TDF and DMPA, FTC/TDF, DMPA
- Where
- Uganda
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Prevention
The CATALYST Study
The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at…
- Trial name
- NCT05937698
- Where
- 28 sites in Kenya, Lesotho and 3 more
- Volunteers
- 6,069 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Prevention
Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females
The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24 regimen.
- Trial name
- NCT02245945
- Testing
- TFV 1% vaginal gel
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- CONRAD