DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Sustiva (Efavirenz) - Summary



SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI).

SUSTIVA (efavirenz) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV RNA.
See all Sustiva indications & dosage >>


Published Studies Related to Sustiva (Efavirenz)

Cyproheptadine for prevention of neuropsychiatric adverse effects of efavirenz: a randomized clinical trial. [2013]
Cyproheptadine prevention of the neuropsychiatric adverse effects of an antiretroviral regimen including efavirenz has been evaluated in a randomized clinical trial. Twenty-five patients (16 males and 9 females with mean±SD ages of 36±9 years) in a cyproheptadine group, and 26 patients (17 males and 9 females with mean±SD ages of 34±7 years) in a control group completed the trial...

A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. [2013]
We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%)...

Efficacy and safety of lersivirine (UK-453,061) versus efavirenz in antiretroviral treatment-naive HIV-1-infected patients: week 48 primary analysis results from an ongoing, multicenter, randomized, double-blind, phase IIb trial. [2013]
activity and safety of lersivirine in treatment-naive HIV-1-infected patients... CONCLUSIONS: Both lersivirine doses showed broadly comparable efficacy to

Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naive HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE Trials. [2012]
THRIVE trials comparing rilpivirine (TMC278) and efavirenz... CONCLUSIONS: At week 48, rilpivirine 25 mg once daily and efavirenz 600 mg once

Efficacy and safety of once-daily nevirapine- or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. [2011.10]
BACKGROUND: Nevirapine (NVP) can be safely and effectively administered once-daily but has not been assessed in human immunodeficiency virus (HIV)-infected patients with tuberculosis (TB). We studied the safety and efficacy of once-daily NVP, compared with efavirenz (EFV; standard therapy); both drugs were administered in combination with 2 nucleoside reverse-transcriptase inhibitors... CONCLUSIONS: Compared with a regimen of didanosine, lamivudine, and EFV, a regimen of once-daily didanosine, lamivudine, and NVP was inferior and was associated with more frequent virologic failure and death. Clinical Trials Registration. NCT00332306.

more studies >>

Clinical Trials Related to Sustiva (Efavirenz)

Sustiva Levels With Use of a Gel Capsule [Completed]
We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.

Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients [Completed]
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.

Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2 [Completed]
The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz [Active, not recruiting]
The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.

Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers [Active, not recruiting]
This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour AUC and Cmax as the primary comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance will also be assessed as secondary outcome measures. This study is a phase I, prospective, within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study, to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after concurrent treatment with American ginseng. The investigators hypothesis is that concurrent oral administration of American ginseng for up to 14 days will not significantly alter the steady-state plasma pharmacokinetic of efavirenz.

more trials >>

Reports of Suspected Sustiva (Efavirenz) Side Effects

Polyhydramnios (9)Lipodystrophy Acquired (8)Rash (7)Nervous System Disorder (7)Tubulointerstitial Nephritis (6)Foetal Exposure During Pregnancy (6)Cholestasis (6)Glomerulonephritis Membranous (6)Polyneuropathy (6)Adverse Event (6)more >>


Based on a total of 1 ratings/reviews, Sustiva has an overall score of 1. The effectiveness score is 8 and the side effect score is 2. The scores are on ten point scale: 10 - best, 1 - worst.

Sustiva review by 45 year old male patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   HIV
Dosage & duration:   600mg taken 1xday for the period of 1 month
Other conditions:   None
Other drugs taken:   Abacavir epivir tenofovir
Reported Results
Benefits:   Lowered viral load and increased t cell count. Also a benefit was the once a day dosing.
Side effects:   Hallucinations and disturbing dreams. These effects were supposed to be temporary and only last a couple of weeks. I was still experiencing them after a month. The whole experience was extremely disturbing.
Comments:   Taken as directed (once a day at night) resulted in nightmarish dreams and waking hallucinations.

See all Sustiva reviews / ratings >>

Page last updated: 2014-11-30

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017