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 IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION (SEE WARNINGS).
ZERIT® is the brand name for stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus (HIV).
ZERIT (stavudine) Capsules are supplied for oral administration in strengths of 15, 20, 30, and 40 mg of stavudine.
ZERIT (stavudine), in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection (see Clinical Studies).
The combination use of ZERIT is based on the results of clinical studies in HIV-infected patients in double- and triple-combination regimens with other antiretroviral agents.
One of these studies (START 1) was a multicenter, randomized, open-label study comparing ZERIT (40 mg twice daily) plus lamivudine plus indinavir to zidovudine plus lamivudine plus indinavir in 202 treatment-naive patients. Both regimens resulted in a similar magnitude of inhibition of HIV RNA levels and increases in CD4 cell counts through 48 weeks.
The efficacy of ZERIT was demonstrated in a randomized, double-blind study (AI455-019, conducted 1992-1994) comparing ZERIT with zidovudine in 822 patients with a spectrum of HIV-related symptoms. The outcome in terms of progression of HIV disease and death was similar for both drugs.
Media Articles Related to Zerit (Stavudine)
FDA approves diagnostic test to differentiate between types of HIV infection
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Kicking latent HIV: New strategies to reactivate reservoirs of latent infection
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In cells with latent HIV infection, the virus is dormant, and such cells are therefore not attacked by the immune system or by standard antiretroviral therapy.
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Source: Medscape Public Health & Prevention Headlines [2015.07.28]
Paying girls to attend high school did not reduce the incidence of HIV infection in a disappointing South African study.
Medscape Medical News
Study finds PrEP use feasible among high-risk groups in US community settings
Source: HIV / AIDS News From Medical News Today [2015.07.22]
A majority of men who have sex with men (MSM) and transgender women (TGW) at high risk for HIV infection took anti-HIV medication for pre-exposure prophylaxis (PrEP), most of the time, in a...
HPTN 052 demonstrates sustained benefit of early antiretroviral therapy
Source: HIV / AIDS News From Medical News Today [2015.07.21]
Antiretroviral therapy (ART) for HIV infection provides lasting protection against the sexual transmission of the virus from infected men and women to their HIV-uninfected sexual partners...
Published Studies Related to Zerit (Stavudine)
Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children. 
BACKGROUND: The aim of this study was to evaluate the pharmacokinetics of lamivudine (3TC), stavudine (d4T) and nevirapine (NVP) in HIV-infected Malawian children receiving quartered tablet multiples of Triomune 40 (generic tablet [GT]) compared with individual generic liquid (GL) and trade liquid (TL)... CONCLUSIONS: Quartered multiples of Triomune 40 are appropriate for children 18-<22 kg and 28-<32 kg in weight; however, alternative formulations are suggested in children weighing 8-<12 kg.
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. 
Lamivudine (CAS 134678-17-4) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.
Bioequivalence study of two fixed dose combination tablet formulations of lopinavir and ritonavir in healthy volunteers. 
The study was designed to compare the rate and extent of absorption of two fixed dose combination tablet formulations of lopinavir (CAS 192725-17-0) and ritonavir (CAS 155213-67-5). This bioequivalence study was conducted using a standard preparation as reference and a generic alternative as test in 72 adult healthy volunteers within 18-45 years of age who received a single dose of the test or reference product under fasting conditions...
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...
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
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
Reports of Suspected Zerit (Stavudine) Side Effects
Lipodystrophy Acquired (11),
Hepatic Function Abnormal (6),
Immune Reconstitution Syndrome (6),
Platelet Count Decreased (6),
Eczema (5), more >>
Page last updated: 2015-07-31