Clinical trials: Tenofovir
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
Healthy, HIV
Comparison of Tenofovir Vaginal Gel and Film Formulations
This is an open label comparative study of tenofovir gel and film in 10 healthy sexually active women without active female genital tract disorders.
- Trial name
- FAME-05 (NCT02280109)
- Testing
- Tenofovir Gel, Tenofovir Film
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- CONRAD
HIV
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
- Trial name
- NCT01691768
- Testing
- 1% tenofovir gel
- Where
- 2 sites in South Africa
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Pharmacokinetic Study in Healthy Volunteers
Single Dose Truvada in HIV-negative Men and Women
This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®.
- Trial name
- TAIL (NCT01326221)
- Testing
- tenofovir + emtricitabine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV
Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel.
- Trial name
- NCT01687218
- Testing
- Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet), Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel), Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
- Where
- 8 sites in United States, Peru and 3 more
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- CONRAD
HIV/AIDS
The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients
This study will assess changes in the incidence and severity of drug interactions before and after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide-based regimens in treatment experienced…
- Trial name
- NCT03789968
- Testing
- bictegravir/emtricitabine/tenofovir alafenamide
- Where
- United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
HIV Prevention
Optimization of a Tenofovir Enema for HIV Prevention
DREAM-01 is an early phase 1, open label, dose-escalation and variable osmolarity study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 formulations of a tenofovir (TFV) enema.
- Trial name
- DREAM-01 (NCT02750540)
- Testing
- Tenofovir enema, Saline enema
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Hepatitis C, HCV
VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect of TVR on the pharmacokinetics of EFV and…
- Conditions
- Hepatitis C, HCV, HIV, AIDS
- Trial name
- NCT00828789
- Testing
- Efavirenz; Tenofovir disoproxil fumarate; Telaprevir
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec BVBA
Drug Interaction
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among…
- Trial name
- NCT04590417
- Testing
- Estradiol valerate 2 mg, cyproterone acetate 25 mg
- Where
- Thailand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Thai Red Cross AIDS Research Centre
Healthy
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI)…
- Trial name
- NCT04661397
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide
- Where
- Netherlands
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
HIV
Examining Hair to Determine Tenofovir Exposure
This study will determine whether a hair test can reveal how much of the anti-HIV medication tenofovir a person without HIV has been exposed to.
- Trial name
- NCT00903084
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
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, Contraception
Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone
The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR), TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate pharmacodynamic (PD) surrogates of contraceptive…
- Trial name
- NCT02235662
- Testing
- TFV IVR, TFV/LNG IVR
- Where
- 2 sites in United States, Dominican Republic
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- CONRAD
HIV Prevention
In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use
- Trial name
- NCT01813162
- Testing
- Tenofovir 1% gel, Vaginal product
- Where
- 2 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- CONRAD
HIV Infections
Prevention of HIV in "Île-de-France"
Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men…
- Trial name
- ANRS-PREVENIR (NCT03113123)
- Testing
- PrEP with Truvada®
- Where
- 22 sites in France
- Volunteers
- 3,257 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
Tenofovir Gel in Pregnancy and Lactation
Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that…
- Trial name
- NCT01136759
- Testing
- Tenofovir 1% gel
- Where
- 2 sites in United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Risk Reduction
PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
Despite advances in HIV prevention, the HIV incidence among young men who have sex with men (YMSM) is increasing, threatening to derail achievement of the United States End the HIV Epidemic goals.
- Trial name
- PrEP2-BAY (NCT05353283)
- Testing
- Motivational Interviewing Counselling, Point-of-care Urine Tenofovir Measurement
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections
PK of Once Daily ART Containing Tenofovir and Atazanavir/Ritonavir
The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral medication used to treat adolescents and young adults with HIV infection.
- Trial name
- NCT00273273
- Testing
- blood draw
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Healthy Volunteer Study
Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir
- Trial name
- NCT06356194
- Testing
- Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK, Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered.
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Transgender Health, Gender Dysphoria
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy.
- Conditions
- Transgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus
- Trial name
- IDENTIFY (NCT04283656)
- Testing
- Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg, Estradiol 2mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University