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Emtriva Medical Research Studies

Up-to-date List of Emtriva 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 Emtriva Medical Research Studies

Rank Status Study
1 Recruiting Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
Condition: HIV Infection
Interventions: Drug: Tenofovir, Emtricitabine, Lopinavir/r;   Drug: Tenofovir, Emtricitabine, Raltegravir
Outcome Measure: Proportion of patients dropping out before the 28 days of postexposure prophylaxis
2 Unknown  Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis
Conditions: Tuberculosis;   HIV Infections
Intervention: Drug: Emtricitabine/tenofovir/efavirenz
Outcome Measures: Pharmacokinetic parameters of emtricitabine, tenofovir and efavirenz;   Pharmacokinetic parameters of the tuberculostatic agents;   Biochemistry and haematology samples for safety;   Questioning about occurrence of adverse events;   CD4 count and HIV-1 RNA;   Sputum staining and culture
3 Recruiting Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Condition: HIV Infection
Interventions: Drug: Maraviroc;   Drug: Emtricitabine;   Drug: Tenofovir disoproxil fumarate;   Other: Maraviroc placebo;   Other: Emtricitabine placebo;   Other: Tenofovir disoproxil fumarate placebo
Outcome Measures: Occurrence of Grade 3 or higher adverse events (AEs);   Tolerability as assessed by time to permanent discontinuation of treatment;   Occurrence of Grade 2 or higher AEs that lead to temporary or permanent hold of study drug;   Changes in creatinine clearance and fractional excretion of phosphate;   Changes in total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) (calculated or measured), and triglycerides;   Changes in bone mineral density (BMD);   Changes in peripheral blood and gut-associated lymphoid tissue (GALT) T cell phenotype;   Pre-dose and post-dose concentrations of MVC, FTC, and tenofovir (TFV) in plasma (Drug Interaction Subset);   Pre-dose concentrations of drugs (MVC, FTC, TFV, and their phosphorylated derivatives), in plasma, peripheral blood mononuclear cells (PBMCs), and rectal and cervical samples (Tissue Subset);   PrEP adherence as assessed by proportion of daily doses taken, measured by electronic drug monitoring (EDM);   Self-reported number of doses missed in last 30 days and self-reported adherence rating scale;   Proportion of doses taken as measured by EDM the day of and day prior to a sexual exposure as detected by SMS assessment;   Selected drug concentration measurements in stored plasma samples;   Self-reported quality of life indicators over time using a standardized assessment tool;   Self-reported sexual behavior over time using a standardized assessment tool;   Occurrence of Grade 1 clinical (non-laboratory) AEs that lead to a temporary or permanent hold of study drug
4 Recruiting Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
Condition: Human Immunodeficiency Virus
Interventions: Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV);   Drug: tenofovir/emtricitabine (TDF/FTC);   Drug: Atazanavir (ATV);   Drug: Ritonavir;   Procedure: Phlebotomy
Outcome Measure: Clearance estimates for each drug, adjusted for age and frailty
5 Recruiting Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B
Conditions: Chronic Hepatitis B e Antigen Positive;   Chronic Hepatitis B e Antigen Negative
Intervention: Drug: Tenofovir/ & amp; Emtricitabine
Outcome Measures: Maintained suppression of HBV DNA below 102 copies/ml (& lt; 95 IU/ml, undetectable by current PCR-based assays, Roche Amplicor assay).;   Normalization of ALT levels and histological improvements which are expected to occur in all patients with full suppression of HBV DNA and in a proportion of those with partial suppression. Other endpoints will be loss of HBeAg and loss of HBsA...
6 Not yet recruiting Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
Conditions: HIV Infection;   Osteopenia
Interventions: Drug: raltegravir and atazanavir and ritonavir;   Drug: tenofovir/emtricitabine and atazanavir and ritonavir
Outcome Measures: Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur);   variations from baseline in CTX (C-terminal telopeptide of type I collagen) and OC (Osteocalcin);   To assess the variation in renal function
7 Unknown  Raltegravir Switch for Toxicity or Adverse Events
Conditions: HIV/AIDS;   Antiretroviral Therapy;   HIV Infections
Interventions: Drug: tenofovir emtricitabine raltegravir;   Drug: Lamivudine Abacavir Raltegravir;   Drug: Abacavir free
Outcome Measures: To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure;   Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis;   Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis;   Evolution of CD4 cell count during the 48 weeks of study;   Evolution of adherence and quality of life during the 48 weeks of study;   Evolution of raltegravir plasma concentrations during the 48 weeks of study;   Evolution of metabolic parameters during the 48 weeks of study;   Change of the results of neurocognitive tests at 48 weeks of study;   Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study
8 Recruiting A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
Condition: Human Immunodeficiency Virus-type 1 Infection
Interventions: Drug: Rilpivirine;   Drug: Efavirenz;   Drug: Tenofovir disoproxil fumarate;   Drug: Emtricitabine
Outcome Measures: Number of patients with plasma HIV-1 RNA levels less than 400 copies per mL;   Number of patients with plasma HIV-1 RNA levels less than 50 copies per mL;   Number of patients with plasma HIV-1 RNA levels more than or equal to 400 copies per mL;   Number of patients with plasma HIV-1 RNA levels more than or equal to 50 copies per mL;   Number of patients with treatment-emergent nucleoside reverse transcriptase inhibitor (N[t]RTI) or nucleoside/nucleotide reverse transcriptase inhibitor (NNRTI) mutations;   Number of adherent patients based on tablet count;   Number of patients with adverse events
9 Not yet recruiting Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir
Condition: HIV
Intervention: Drug: Rilpivirine/Emtricitabine/Tenofovir
Outcome Measures: Explore Efficacy;   HIV RNA levels
10 Unknown  Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
Condition: HIV Infections
Interventions: Drug: Lopinavir/Ritonavir;   Drug: Emtricitabine;   Drug: Stavudine
Outcome Measure:
11 Not yet recruiting First-Line Treatment for HIV-2
Condition: HIV-2 Infection
Interventions: Drug: Tenofovir + Emtricitabine or Lamivudine + Zidovudine;   Drug: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir;   Drug: Tenofovir + Emtricitabine or Lamivudine + Raltegravir
Outcome Measures: The "overall success";   Therapeutic failure;   Incidence and type of severe clinical or biological severe adverse events (grade 3 or 4 on the ANRS grading table) per arm;   The clinical progression;   The evolution of CD4 counts;   The evolution of plasma HIV-2 RNA load;   The observance of antiretroviral treatment;   The resistance mutations profile;   The evolution of the HIV-2 DNA titers in PBMC;   The frequency of treatment switches and discontinuations;   To model the long-term survival and cost-effectiveness ratio
12 Recruiting Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.
Condition: HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
Intervention: Drug: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
Outcome Measures: To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera;   To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
13 Not yet recruiting Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
Condition: HIV Infections
Interventions: Drug: Raltegravir (MK-0518);   Drug: Nevirapine;   Drug: Lamivudine;   Drug: Tenofovir;   Drug: Emtricitabine;   Drug: Lopinavir;   Drug: Ritonavir;   Drug: Atazanavir;   Drug: Darunavir
Outcome Measures: Change from Baseline in Renal Function;   Percentage of Participants with Decline in Renal Function at Week 48;   Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48;   Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 RNA) at Week 96;   Percentage of Participants with Decline in Renal Function at Week 96
14 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
15 Recruiting Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
Condition: HIV
Interventions: Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet);   Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel);   Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
Outcome Measures: Saftey Profiling;   Acceptability;   Pharmacokinetics;   Adherence
16 Recruiting A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: Dolutegravir/abacavir/lamivudine FDC;   Drug: Atazanavir;   Drug: Ritonavir;   Drug: Tenofovir/emtricitabine FDC
Outcome Measures: Proportion of subjects with plasma HIV-1 ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48;   Proportion of subjects with plasma HIV-1 RNA <50 c/mL and <400 c/mL over time;   Absolute values and change from Baseline in plasma HIV-1 RNA over time;   Absolute values and changes from Baseline in CD4+ cell counts over time;   Incidence of disease progression;   Incidence and severity of adverse events (AEs) and proportion of subjects who discontinue treatment due to AEs;   Incidence, severity, absolute values and changes over time in laboratory parameters abnormalities;   Change from Baseline in fasting lipids and glucose;   Changes from Baseline in renal and bone markers;   Change from Baseline in health related quality of life and treatment satisfaction;   Incidence of treatment emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria
17 Recruiting Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
Conditions: Acquired Immunodeficiency Syndrome;   HIV Infections
Intervention: Drug: EVG/COBI/FTC/TDF
Outcome Measures: For Part A, plasma pharmacokinetics (PK) parameter of EVG as measured by AUCtau;   For Part B, incidence of treatment-emergent serious adverse events (SAEs) and all treatment-emergent adverse events (AEs);   For Part A, PK parameter of EVG as measured by Ctau and Cmax and PK parameter of emtricitabine (FTC), tenofovir (TFV), and cobicistat (COBI) as measured by AUCtau, Cmax, and Ctau;   For Part B, percentage of participants with plasma HIV-1 RNA < 50 copies/mL;   For Part B, percentage of participants with plasma HIV-1 RNA < 400 copies/mL;   For Part B, change from baseline in plasma log10 HIV-1 RNA (copies/mL);   For Part B, change from baseline in CD4+ cell count (cells/μL) and percentage
18 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
19 Recruiting Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
Condition: HIV
Intervention: Drug: ATRIPLA
Outcome Measures: Proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis.;   The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks.;   The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells;   Immunological;   Changes in plasma levels of efavirenz.;   Changes in sleep quality (Pittsburgh Sleep Quality Index).;   General Safety (report adverse events, serious adverse events and treatment discontinuation due to adverse events);   Changes in plasma levels of vitamin D.;   Changes in lipid profile.;   Changes in estimated glomerular filtration rate.
20 Recruiting Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults
Conditions: HIV;   HBV
Intervention: Drug: E/C/F/TAF
Outcome Measures: Percentage of participants with plasma HBV DNA levels < 29 copies/mL;   Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL per the FDA snapshot definition;   Percentage of participants with plasma HIV-1 RNA level < 50 copies/mL per FDA snapshot definition;   Percentage of participants with normalized alanine aminotransferase (ALT);   Percentage of participants with seroconversion;   Change in FibroTest® score

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

A major focus of Emtriva 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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