WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING STAVUDINE AND OTHER ANTIRETROVIRALS. FATAL LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF STAVUDINE AND DIDANOSINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION OF STAVUDINE AND DIDANOSINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL RISK (SEE WARNINGS AND PRECAUTIONS: PREGNANCY).
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WHEN ZERIT WAS PART OF A COMBINATION REGIMEN THAT INCLUDED DIDANOSINE, WITH OR WITHOUT HYDROXYUREA, IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION (SEE WARNINGS).
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ZERIT SUMMARY
ZERIT®(stavudine)
ZERIT® (stavudine) Capsules
ZERIT® (stavudine) for Oral Solution
ZERIT® is the brand name for stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the Human Immunodeficiency Virus (HIV).
ZERIT (stavudine), in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection.
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NEWS HIGHLIGHTS
Published Studies Related to Zerit (Stavudine)
Changes in body composition with ritonavir-boosted and unboosted atazanavir treatment in combination with Lamivudine and Stavudine: a 96-week randomized, controlled study. [2009.05.01]
This 96-week, open-label, randomized study assessed changes in body composition in treatment-naive patients infected with human immunodeficiency virus type 1 who were treated with either atazanavir or ritonavir-boosted atazanavir, in combination with stavudine and lamivudine.
A single-dose, randomized, open-label, two-period crossover bioequivalence study comparing a fixed-dose pediatric combination of lamivudine and stavudine tablet for oral suspension with individual liquid formulations in healthy adult male volunteers. [2009]
Lamivudine (CAS 134678-17-4) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.
The influence of lamivudine, stavudine and nevirapine on the pharmacokinetics of chlorpropamide in human subjects. [2008.07]
Diabetic patients tend to be prone to infections, and multiple drug therapy cannot be ruled out in the management of diabetes. The effect of three routinely prescribed antiretroviral (ARV) drugs on the pharmacokinetic profile of an antidiabetic drug, chlorpropamide, was investigated in 18 human subjects, who had recently been diagnosed positive for human immunodeficiency virus (HIV) infection...
Long-term subcutaneous tissue changes among antiretroviral-naive persons initiating stavudine, zidovudine, or abacavir with lamivudine. [2008.05.01]
OBJECTIVES: To assess long-term changes in subcutaneous tissue among antiretroviral-naive persons initiating 1 of 3 nucleoside reverse transcriptase inhibitor (NRTI)-containing regimens... CONCLUSIONS: In this prospective nonrandomized evaluation, subcutaneous tissue changes varied by regimen. Similar losses were demonstrated for d4T+3TC and ZDV+3TC, whereas ABC+3TC had gains. Temporal differences in rates for d4T+3TC and ZDV+3TC suggest initial recovery followed by long-term treatment effect.
The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy. [2007.11]
CONCLUSION: In virologically suppressed patients, switching d4T to TDF as part of a once-daily regimen with 3TC and EFV resulted in maintenance of virologic suppression and continued CD4 cell increases through 144 weeks, with significant improvements in metabolic parameters.
Clinical Trials Related to Zerit (Stavudine)
Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY [Active, not recruiting]
Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to
stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced
doses of stavudine (30 mg b. i.d.) in HIV patients with controlled viral load and body weight
> 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b. i.d.
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children [Completed]
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone
and in combination with didanosine (ddI), and whether concurrent administration alters the
disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long
term changes from baseline in plasma HIV RNA concentrations. To determine the relationship,
if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the
three children with baseline counts greater than 50 cells/micro liter experienced a 20%
increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the
same regimen for children with less advanced HIV disease should be undertaken.
The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine [Completed]
To determine the potential effects of 28 days of nevirapine treatment on the steady-state
pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the
pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the
historical controls treated with nevirapine but without nelfinavir or d4T. To determine the
efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in
patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease
inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment [Active, not recruiting]
The purpose of this study is to see how effective and safe it is to give 1 of the 3 following
treatments to patients who may not have received anti-HIV treatment: 1) lamivudine
(3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir
(APV)/ritonavir (RTV).
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection. [Completed]
To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence
of recent HIV infection.
Also, to compare the immunologic effects and effects on quality of life of d4T in these
patients.
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Page last updated: 2009-10-20
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