NEWS HIGHLIGHTSMedia Articles Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM
Efavirenz Gets Expanded Indication for HIV
Source: Medscape HIV/AIDS Headlines [2013.05.07]
The FDA has approved efavirenz for HIV infection in children as young as 3 months who weigh at least 3.5 kg.
FDA Approvals
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
Published Studies Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz. [2011.06]
Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects... Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.
Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. [2011.03.27]
OBJECTIVE: To assess the safety and efficacy of two, single-tablet regimens for the initial treatment of HIV infection. DESIGN: Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study... CONCLUSION: Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current standard-of-care regimen of EFV/FTC/TDF.
Concomitant administration of BILR 355/r with emtricitabine/tenofovir disoproxil fumarate increases exposure to emtricitabine and tenofovir: a randomized, open-label, prospective study. [2011.03]
The objective of this study was to evaluate the pharmacokinetic interaction of ritonavir-boosted BILR 355 (BILR 355/r) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). This was an open-label, prospective study... There was no evidence of increased risk of TFV or FTC toxicity upon co-administration of FTC/TDF with BILR 355/r.
Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. [2010.02]
A randomized, open-label, multicenter study was conducted to evaluate the therapeutic switch to a single-tablet formulation of efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) among virologically suppressed, HIV-1-infected subjects. Eligible subjects on stable antiretroviral therapy (ART) with HIV-1 RNA less than 200 copies per milliliter for 3 months or more were stratified by prior protease inhibitor (PI)- or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy and randomized (2:1) to EFV/FTC/TDF or to stay on their baseline regimen (SBR)...
Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. [2009.06.01]
OBJECTIVE: To evaluate a simplification strategy for HIV-1-infected patients virologically suppressed on antiretroviral therapy (ART) by switching to a single-tablet regimen consisting of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). DESIGN:: Prospective, randomized, controlled, open-label, multicenter study... CONCLUSION: Simplification to EFV/FTC/TDF maintained high and comparable rates of virologic suppression vs. SBR through 48 weeks.
Clinical Trials Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women [Recruiting]
This Phase III, double-blind, randomized, placebo-controlled trial will enroll an estimated
3900 HIV-negative women from 7 sites in 5 countries (Kenya, Malawi, Tanzania,South
Africa,Zambia and Zimbabwe). The study's purpose is to investigate the safety and
effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among
HIV-uninfected women at risk of becoming infected through sexual intercourse.
The study population includes HIV-antibody-negative women between the ages of 18-35 who are
at risk of HIV acquisition through sexual intercourse. Each participant will be randomized
to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of
emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical
placebo. All participants will receive risk reduction counseling and condoms. Women must be
using a study-approved effective non-barrier contraceptive method at the time of enrollment
and will be asked to do so for the whole period they are on study drug. They will receive
contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted
infection will be treated free of charge.
Study duration is approximately 37-40 months at each site; participant screening and
enrollment is anticipated to take approximately 12-16 months. After enrollment, each
participant will be followed every four weeks for 52 weeks on study drug. All participants
will be followed for an additional four weeks after study drug has been stopped.
Participants at risk for hepatitis B virus (HBV) flare will be followed every four weeks
for at least 12 weeks after stopping study product. Participants who acquire HIV infection
during the study will stop taking the study drug at the time of HIV diagnosis, will be
followed for 52 weeks post diagnosis and will be referred for care and treatment.
Participants who become pregnant will stop taking the study drug but will continue follow-up
visits. After the study, incidence rates of HIV infection will be compared between the two
groups (active drug and placebo) using the intent-to-treat principle.
Boosted Atazanavir and Truvada Given Once-Daily - BATON Study [Completed]
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen
consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir
boosted with ritonavir in treatment naive patients.
Raltegravir vs. Atazanavir in Combination With Truvada� for the Treatment of Antiretroviral na�ve HIV Infected Patients [Recruiting]
This is a pilot that will evaluate two regimens for treating HIV infected patients that
haven't been on treatment before. HIV/AIDS patients may have an increased risk of
myocardial infarction and antiretroviral therapy used may contribute to this. We will
evaluate virological, immunological and cardiovascular effects of two HIV treatment
regimens.
A Dose-Ranging Study to Compare MK-1439 Plus TRUVADA� Versus Efavirenz Plus TRUVADA� in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007 AM9) [Recruiting]
Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy
(antiretroviral activity) of 4 doses of MK-1439 compared with efavirenz, when each is given
in combination with TRUVADA® for at least 24 weeks in approximately 200 participants. A
single dose of MK-1439 will be selected for further study after all participants complete
the Week 24 visit in Part 1. Participants receiving any dose of MK-1439 in Part 1 will be
switched to the selected MK-1439 dose and continue in the study for up to 96 weeks.
Part 2 - Selected Dose. Part 2 will be initiated after the MK-1439 dose has been selected as
indicated above for Part 1. Approximately 120 additional participants will be randomized in
1: 1 ratio to the selected dose of MK-1439 or efavirenz, each in combination with TRUVADA®
for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected dose
compared with efavirenz, particularly with regard to central nervous system adverse events
(CNS events).
The hypothesis tested in this study is that MK-1439 at the final dose selected is superior
to efavirenz, each given in combination with TRUVADA®, as measured by the proportion of
participants with CNS events by Week 8. If superiority is established at Week 8, the same
hypothesis will be tested for Week 24.
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP) [Recruiting]
This study will evaluate the safety and tolerability of the combination of truvada and
raltegravir given for 28 days for the prevention of HIV infection.
Reports of Suspected Truvada (Emtricitabine / Tenofovir Disoproxil) Side Effects
Foetal Exposure During Pregnancy (139),
Maternal Exposure During Pregnancy (70),
Abortion Spontaneous (63),
Renal Failure Acute (47),
Abortion Induced (33),
Pyrexia (28),
Anaemia (28),
Stillbirth (26),
Patent Ductus Arteriosus (24),
Premature Baby (23), more >>
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