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Truvada Medical Research Studies

Up-to-date List of Truvada Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Truvada Medical Research Studies

Rank Status Study
1 Recruiting An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Condition: HIV Infection
Interventions: Behavioral: 3MV;   Behavioral: PCC;   Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Outcome Measures: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM;   Acceptability, patterns of use, rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.;   Behavioral disinhibition/risk compensation;   Evaluation of the process of protocol implementation;   Acceptability and feasibility of two types of efficacious sexual risk reduction interventions as measured by session evaluation (i.e., was session interesting, was it relevant to their life, and did they learn from the session);   Acceptability and feasibility of text message reminders as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.;   Demographic and/or behavioral difference between study groups. Behavioral disinhibition/risk compensation endpoints will be compared.;   Explore potential demographic and/or behavioral differences between youth who are interested in participating in a PrEP study versus those who are not. Behavioral disinhibition/risk compensation endpoints will be compared.
2 Recruiting Pre-exposure Option for Reducing HIV in the UK.(PROUD)
Condition: HIV
Intervention: Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
Outcome Measures: Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation;   HIV infections acquired between trial entry and 12 months, and between 12 and 24 months
3 Recruiting Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With Truvada™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
Condition: HIV Infection
Interventions: Drug: Reformulated Raltegravir;   Drug: Raltegravir;   Drug: Truvada™;   Drug: Placebo to Reformulated Raltegravir;   Drug: Placebo to Raltegravir
Outcome Measures: Percentage of Participants Achieving <40 copies/mL HIV-1 Ribonucleic Acid (RNA) at Week 48;   Change from Baseline in Cluster of Differentiation (CD4) Cell Count at Week 48;   Percentage of Participants Achieving <40 copies/mL HIV-1 RNA at Week 96;   Change from Baseline in CD4 Cell Count at Week 96;   Percentage of Participants with an Adverse Experience;   Percentage of Participants with a Drug-Related Adverse Experience;   Percentage of Participants with a Serious Adverse Experience;   Percentage of Participants with a Serious and Drug-Related Adverse Experience;   Percentage of Participants Discontinued from Drug Therapy Due to an Adverse Experience
4 Unknown  Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
Condition: HIV Infections
Interventions: Drug: lamivudine, abacavir , ritonavir, atazanavir;   Drug: emtricitabine, tenofovir, ritonavir, atazanavir
Outcome Measures: antiretroviral effect over 48 weeks;   The immunologic effects from baseline at the 48th and 144th week;   Reasons of treatment failure by 144th week;   Adverse events and their rate of incidence by 144th week
5 Recruiting On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
Condition: HIV Infection
Interventions: Drug: Truvada;   Drug: Placebo
Outcome Measures: Contamination with HIV-1 or -2;   Evolution of sexual behavior and potential at-risk behavior;   Incidence of clinical and biological adverse events;   Treatment adherence;   Incidence of hepatitis B;   Incidence of other sexually transmitted diseases;   Frequency of HIV resistance to antiretrovirals in HIV infected subjects;   Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples.;   Costs evaluation
6 Recruiting Seroconversions, Resistance, Adverse Events and Drug Adherence Among Subjects Taking Truvada® for PrEP: A Case Control Study
Condition: HIV
Intervention:
Outcome Measures: Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP;   Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment;   Time to seroconversion during during treatment
7 Unknown  Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
Condition: HIV Infections
Interventions: Drug: raltegravir (Isentress);   Drug: Truvada®
Outcome Measure: To assess the nature and incidence of drug intolerance and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.
8 Recruiting A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
Condition: HIV
Intervention:
Outcome Measures: Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication;   Proportion of seroconverters with resistance mutations;   Proportion of seroconverters with signs/symptoms at or before seroconversion
9 Recruiting Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
Condition: PrEP Adherence Monitoring
Intervention: Drug: Truvada
Outcome Measures: TFV-DP pharmacokinetics for different dosing patterns of Truvada;   Establish a model to predict adherence rate by TFV-DP in DBS;   "intermittent" versus "holiday" pattern of dosing;   Describe tenofovir and emtricitabine pharmacokinetics;   Fingerstick DBS versus DBS from venipuncture;   Interpret DBS concentrations from PrEP demonstration projects
10 Recruiting A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
Condition: HIV Infection
Intervention:
Outcome Measures: Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP;   Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals
11 Recruiting A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
Condition: Pre-exposure Prophylaxis for Prevention of HIV Infection
Intervention:
Outcome Measures: Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy;   Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication;   Demographics of prescribers of FTC/TDF for a PrEP indication
12 Not yet recruiting Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India
Condition: HIV Infection
Intervention: Drug: Truvada
Outcome Measures: Sustained uptake and adherence to oral PrEP among female sex workers;   Identification of female sex workers willing to take PrEP;   Oral HIV PrEP as part of a combined prevention package delivered safely for female sex workers;   Effective delivery of oral HIV PrEP demonstrated in context of National Targeted Interventions
13 Not yet recruiting A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection
Conditions: Infection;   HIV
Intervention: Drug: Truvada and Isentress
Outcome Measures: Safety;   HIV seroincidence
14 Recruiting Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine
Condition: HIV+
Intervention:
Outcome Measure: Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA)
15 Recruiting Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
Conditions: HIV;   Impaired Cognition
Interventions: Drug: standard care;   Drug: novel treatment
Outcome Measures: cognitive function;   brain function
16 Not yet recruiting A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM: The PREPARATORY-5 Study
Conditions: HIV;   Human Immunodeficiency Virus
Intervention: Drug: Tenofovir/emtricitabine
Outcome Measures: Participants' self-reported overall acceptability of PrEP;   The level of community interest in PrEP;   Adherence to daily TDF/FTC-based PrEP;   Time required by the patient, physician and research coordinator for each type of study visit.;   HIV infection;   Sexually transmitted infections;   Burden of syndemic health problems;   Change in estimated glomerular filtration rate;   Percentage change in bone mineral density at the lumbar spine and total hip;   Adverse events
17 Recruiting A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
Condition: HIV Prevention
Intervention: Drug: emtricitabine 200mg/tenofovir 300mg
Outcome Measures: Safety: Adverse events/Serious Adverse Events;   Adherence to daily FTC/Tenofovir
18 Recruiting Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
Condition: HIV-2 Infection
Intervention: Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .
Outcome Measures: Proportion of participants in therapeutic success;   Gain in CD4 lymphocytes count;   Tolerance of the treatment;   Evolution of the number and percentage of CD4 lymphocytes;   Evolution of plasma HIV-2 RNA load;   The rate of clinical progression will be defined as the switch;   Adherence evaluated with ANRS self-administered questionnaire of adherence and plasma measurements of residual concentrations of antiretroviral drugs in viral failure cases;   Description of the resistance mutations'profile in virological failure cases;   Frequency of treatment switch or discontinuation;   Evolution of plasma HIV-2 DNA load in PBMC;   Evolution of the quality of life
19 Not yet recruiting Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen
Condition: HIV Disease
Intervention: Drug: Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)
Outcome Measures: Neurometabolites based on MRS;   Neural activation networks using fMRI;   Other neurometabolite changes measured by MRS;   Neurocognitive changes;   Fasting lipid profile;   Sleep quality;   ART regimen preference;   Markers of immune activation
20 Recruiting Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Conditions: HIV Infection;   Hepatitis C
Interventions: Drug: Anti-HIV Agents;   Drug: raltegravir;   Drug: Emtricitabine and tenofovir disoproxil fumarate
Outcome Measures: HCV RNA;   HIV RNA;   ISG

These studies may lead to new treatments and are adding insight into Truvada etiology and treatment.

A major focus of Truvada research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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