WARNING
FATAL AND NONFATAL PANCREATITIS HAVE 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). LACTIC 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: PREGNANCY).
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VIDEX EC SUMMARY
VIDEX® EC (didanosine) is the brand name for an enteric-coated formulation of didanosine (ddl), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). VIDEX EC (didanosine) Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine.
VIDEX EC (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults.
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NEWS HIGHLIGHTSMedia Articles Related to Videx EC (Didanosine)
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
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)
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 Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine [Completed]
To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI
combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV
activity data using immunologic and virologic markers.
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and
ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase
inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected
patients may prove more effective.
Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex [Completed]
To compare the safety and effectiveness of orally administered didanosine (ddI) with high
dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of
the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses
of up to 1000 mg/day.
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC
may be caused by some action of the AIDS virus on the nervous system, although similar
problems can be caused by other infections because the AIDS virus lowers the body's ability
to fight other infections. It is important to determine whether symptoms are due to ADC or to
some other infection since treatment varies for different conditions. AZT has been shown to
be beneficial to people with ADC although its effectiveness has only been studied in a small
number of patients. Studies suggest that higher doses of AZT are more likely to be effective
than standard doses in improving symptoms of ADC.
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection [Active, not recruiting]
To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine
(ddI) in children with HIV infection.
New approaches to using available agents may provide increased or improved treatment options
for AIDS. Combination therapy is expected to play a major role in improving survival and
quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most
extensively evaluated and for which the evidence for antiretroviral effectiveness is
strongest.
Reports of Suspected Videx EC (Didanosine) Side Effects
Malignant Melanoma (2),
Confusional State (1),
Portal Hypertension (1),
Pulmonary Hypertension (1),
Headache (1),
Lactic Acidosis (1),
Multi-Organ Failure (1),
Fatigue (1),
Neuropathy Peripheral (1),
Basal Cell Carcinoma (1), more >>
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Page last updated: 2013-05-04
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