WARNING: PANCREATITIS, LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS
Fatal and nonfatal pancreatitis
has occurred during therapy with didanosine used alone or in combination regimens
in both treatment-naive and treatment-experienced patients, regardless of
degree of immunosuppression. VIDEX EC should be suspended in patients with
suspected pancreatitis and discontinued in patients with confirmed pancreatitis
[see Warnings and Precautions
acidosis and severe hepatomegaly with steatosis, including fatal cases, have
been reported with the use of nucleoside analogues alone or in combination,
including didanosine and other antiretrovirals. Fatal lactic acidosis has
been reported in pregnant women who received the combination of didanosine
and stavudine with other antiretroviral agents. The combination of didanosine
and stavudine should be used with caution during pregnancy and is recommended
only if the potential benefit clearly outweighs the potential risk [see
Warnings and Precautions
VIDEX EC SUMMARY
is the brand name for an enteric-coated formulation of didanosine, USP, a
synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release
Capsules, containing enteric-coated beadlets, are available for oral administration
in strengths of 125, 200, 250, and 400 mg of didanosine.
(didanosine, USP), also known as ddI, in combination with other antiretroviral
agents is indicated for the treatment of human immunodeficiency virus (HIV)-1
infection [ see Clinical Studies
Media Articles Related to Videx EC (Didanosine)
U.S. Perinatal HIV Infection Fell to 69 Infants in 2013: CDC
Source: Medscape HIV/AIDS Headlines [2017.03.23]
Perinatal HIV infection steadily declined in the U.S. between 2002 and 2013, but “missed opportunities” remain for preventing transmission, according to new research from the Centers for Disease Control and Prevention (CDC).
Reuters Health Information
Acute HIV infection: Symptoms, diagnosis, and management
Source: HIV / AIDS News From Medical News Today [2017.03.11]
How is acute HIV infection diagnosed, what are the causes, and what is the outlook? How can an acute HIV infection be managed and can it be prevented?
Genetics of both virus and patient work together to influence the course of HIV infection
Source: HIV / AIDS News From Medical News Today [2017.02.09]
A patient's genetics may impact disease progression by inducing mutations in the HIV genome.
HIV rash: What does it look like and how long does it last?
Source: HIV / AIDS News From Medical News Today [2017.02.22]
Rashes are one of the earliest symptoms of an HIV infection. Learn about the types of rash that can occur, their duration, and treatment options.
Published Studies Related to Videx EC (Didanosine)
Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). [2011.01]
BACKGROUND: once-daily combinations of efavirenz and two nucleoside analogues are recommended for the treatment of HIV infection. Long-term efficacy and safety data are scarce for the combination of efavirenz, emtricitabine and didanosine... CONCLUSIONS: a once-daily regimen of emtricitabine, didanosine and efavirenz provided a durable antiretroviral response and was well tolerated through 4 years of therapy.
Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. [2009.05.01]
BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa... CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART.
Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. [2008.10.15]
BACKGROUND: The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials... CONCLUSIONS: At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. CLINICAL TRIALS REGISTRATION: NCT00256828.
Low-level K65R mutation in HIV-1 reverse transcriptase of treatment-experienced patients exposed to abacavir or didanosine. [2007.10.01]
BACKGROUND: Prior abacavir (ABC) or didanosine (ddI) therapy can result in the L74V/I or K65R mutation in HIV-1 reverse transcriptase. Preexisting K65R may have an impact on the treatment response to tenofovir disoproxil fumarate (TDF)... CONCLUSIONS: Prior therapy with ABC or ddI can result in a population genotype that shows K65R or L74V/I but does not reveal low-level K65R present in some patients. Subsequent treatment intensification with TDF resulted in a poor virologic response and may result in expansion of the preexisting K65R mutant.
Stavudine but not didanosine as part of HAART contributes to peripheral lipoatrophy: a substudy from the Antiretroviral Regimen Evaluation Study (ARES). [2007.09]
CONCLUSION: This study suggests that didanosine/lamivudine, when combined with either nevirapine or ritonavir-boosted saquinavir over 96 weeks of therapy, is possibly not associated with limb fat atrophy, in contrast to when treatment contained didanosine, stavudine, and nelfinavir combined.
Clinical Trials Related to Videx EC (Didanosine)
Bioequivalence Study of Didanosine in Children Treated for HIV [Suspended]
The purpose of this study is to show that the administration of 400/mg/m2/day of
didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of
didanosine during fasting, in HIV infected children treated by a ARV combination including
Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults [Active, not recruiting]
The purpose of this study is to compare gastrointestinal (stomach and intestines) side
effects of 2 forms of Videx in HIV-infected patients.
Videx can be an effective anti-HIV treatment but many patients will not take the medication
due to its side effects. Videx EC is a capsule form of the drug and may have fewer side
effects. Also, patients would not have to take as many pills since patients taking Videx EC
would have to take only 1 capsule per day instead of 2 tablets per day. This study will see
if patients taking Videx EC have fewer side effects.
A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) [Completed]
The objective of this treatment IND protocol is to make didanosine (ddI) available to
patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have
developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program
due to protocol exclusion or geographic location.
A Study Comparing Two Forms of Didanosine in HIV-infected Patients [Completed]
The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as
safe and absorbed by the body as well as the chewable-tablet form of ddI.
Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in
the stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of
ddI may replace the need for antacids.
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI) [Completed]
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a
new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily
and hopefully will prevent stomach upset. The purpose of this study is to compare the
effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given
with stavudine (d4T) plus nelfinavir (NLF).
Reports of Suspected Videx EC (Didanosine) Side Effects
Malignant Melanoma (2),
Confusional State (1),
Portal Hypertension (1),
Pulmonary Hypertension (1),
Lactic Acidosis (1),
Multi-Organ Failure (1),
Neuropathy Peripheral (1),
Basal Cell Carcinoma (1), more >>
Page last updated: 2017-03-23