NEWS HIGHLIGHTS
Published Studies Related to Sustiva (Efavirenz)
Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. [2009.09.05]
BACKGROUND: Use of raltegravir with optimum background therapy is effective and well tolerated in treatment-experienced patients with multidrug-resistant HIV-1 infection. We compared the safety and efficacy of raltegravir with efavirenz as part of combination antiretroviral therapy for treatment-naive patients... INTERPRETATION: Raltegravir-based combination treatment had rapid and potent antiretroviral activity, which was non-inferior to that of efavirenz at week 48. Raltegravir is a well tolerated alternative to efavirenz as part of a combination regimen against HIV-1 in treatment-naive patients. FUNDING: Merck.
A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. [2009.08.15]
BACKGROUND: Long-term antiretroviral therapy dramatically reduces HIV-related morbidity and mortality but is also associated with metabolic and morphological changes and requires high levels of adherence... CONCLUSIONS: Switching from zidovudine/lamivudine to tenofovir disoproxil fumarate/emtricitabine in persons on efavirenz therapy maintains virological control, establishes a once-daily regimen, results in improvements in hemoglobin and key lipid parameters, and preserves and restores limb fat relative to continuation of zidovudine/lamivudine.
Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. [2009.08.04]
BACKGROUND: More than 50% of patients who start efavirenz treatment develop limiting neuropsychiatric adverse events (NPAEs). OBJECTIVE: To assess whether stepwise dosing of efavirenz decreases the incidence and severity of NPAEs while maintaining virologic efficacy... CONCLUSION: Stepwise dose escalation of efavirenz over 2 weeks reduces the incidence and intensity of efavirenz-related NPAEs while maintaining efficacy. PRIMARY FUNDING SOURCE: Consejeria de Salud, Junta de Andalucia, Spain.
Effects of oral posaconazole on the pharmacokinetics of atazanavir alone and with ritonavir or with efavirenz in healthy adult volunteers. [2009.08.01]
BACKGROUND: Patients with HIV/AIDS are at increased risk for opportunistic fungal infections. These patients may require concomitant treatment with antiretrovirals and azole antifungals, and interactions between these classes of drugs should be anticipated... CONCLUSIONS: Frequent monitoring of adverse events and toxicity related to antiviral exposure is recommended in the event of coadministration of posaconazole and ATV with or without ritonavir. In addition, because of decreased posaconazole exposure, coadministration with efavirenz should be avoided unless the benefit to patients outweighs the risk.
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 Sustiva (Efavirenz)
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients [Active, not recruiting]
This is a study on the utility of the modification of doses of efavirenz guided by its plasma
concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment
with Sustiva.
Study of Treatment of Antiretroviral-Naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz. [Active, not recruiting]
To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus
efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral
drugs and have a viral load of less than 400 copies/mL at week 48.
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz [Completed]
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will
enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based
regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg
daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in
this study.
Primary Objective:
To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with
efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without
efavirenz.
Tenofovir Disoproxil Fumarate (DF)/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects [Active, not recruiting]
The purpose of this study is to assess two regimens in antiretroviral-naive subjects.
A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects [Completed]
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