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VIDEX (Powder, For Solution)

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dailymed-drugs:3624rdfs:labelVIDEX (Powder, For Solution)lld:dailymed
dailymed-drugs:3624dailymed-instance:dosageDosage: VIDEX should be administered on an empty stomach, at least 30 minutes before or 2 hours after eating. Adults: The preferred dosing frequency of VIDEX is twice daily because there is more evidence to support the effectiveness of this dosing regimen. Once-daily dosing should be considered only for adult patients whose management requires once-daily dosing of VIDEX . The daily dose in adult patients is dependent on weight as outlined in Table 13. Pediatric Patients: The recommended dose of VIDEX (didanosine) in pediatric patients between 2 weeks and 8 months of age is 100 mg/mtwice daily, and the recommended VIDEX dose for pediatric patients older than 8 months is 120 mg/mtwice daily. Dosing recommendations for VIDEX in patients less than 2 weeks of age cannot be made because the pharmacokinetics of didanosine in these children are too variable to determine an appropriate dose. There are no data on once-daily dosing of VIDEX in pediatric patients.<br/>Dose Adjustment: Clinical and laboratory signs suggestive of pancreatitis should prompt dose suspension and careful evaluation of the possibility of pancreatitis. VIDEX use should be discontinued in patients with confirmed pancreatitis (see WARNINGS and PRECAUTIONS: Drug Interactions). Patients with symptoms of peripheral neuropathy may tolerate a reduced dose of VIDEX after resolution of the symptoms of peripheral neuropathy upon drug discontinuation. If neuropathy recurs after resumption of VIDEX, permanent discontinuation of VIDEX should be considered. Concomitant Therapy: Tenofovir disoproxil fumarate. A dose reduction of VIDEX to 250 mg (adults weighing���60 kg with creatinine clearance���60 mL/min) or 200 mg (adults weighing<60 kg with creatinine clearance���60 mL/min) once daily is recommended. VIDEX and tenofovir may be taken together in the fasted state. Alternatively, if tenofovir is taken with food, VIDEX should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food). The appropriate dose of VIDEX coadministered with tenofovir in patients with creatinine clearance<60 mL/min has not been established. [See CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: Drug Interactions; see the complete prescribing information for VIDEX EC (enteric-coated formulation of didanosine) for results of drug interaction studies of tenofovir with reduced doses of the enteric-coated formulation of didanosine.] Renal Impairment: In adult patients with impaired renal function, the dose of VIDEX should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of VIDEX in adult patients with renal insufficiency are presented in Table 14. Urinary excretion is also a major route of elimination of didanosine in pediatric patients; therefore, the clearance of didanosine may be altered in children with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of VIDEX in this patient population, a reduction in the dose and/or an increase in the interval between doses should be considered. Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis: For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance less than 10 mL/min, shown in Table 14. It is not necessary to administer a supplemental dose of VIDEX following hemodialysis. Hepatic Impairment and Toxicity: See WARNINGS.<br/>Method of Preparation:<br/>VIDEX Pediatric Powder for Oral Solution: Prior to dispensing, the pharmacist must constitute dry powder with Purified Water, USP, to an initial concentration of 20 mg/mL and immediately mix the resulting solution with antacid to a final concentration of 10 mg/mL as follows: 20 mg/mL Initial Solution: Constitute the product to 20 mg/mL by adding 100 mL or 200 mL of Purified Water, USP, to the 2 g or 4 g of VIDEX powder, respectively, in the product bottle. 10 mg/mL Final Admixture: 1. Immediately mix one part of the 20 mg/mL initial solution with one part of Maximum Strength Mylanta Liquid for a final dispensing concentration of 10 mg VIDEX per mL. For patient home use, the admixture should be dispensed in appropriately sized, flint-glass or plastic (HDPE, PET, or PETG) bottles with child-resistant closures. This admixture is stable for 30 days under refrigeration, 36��to 46��F (2��to 8��C). 2. Instruct the patient to shake the admixture thoroughly prior to use and to store the tightly closed container in the refrigerator, 36��to 46��F (2��to 8��C), up to 30 days.lld:dailymed
dailymed-drugs:3624dailymed-instance:descripti...VIDEX (didanosine) is a brand name for didanosine (ddI), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). VIDEX Pediatric Powder for Oral Solution is supplied for oral administration in 4- or 8-ounce glass bottles containing 2 or 4 grams of didanosine, respectively. Didanosine is also available as an enteric-coated formulation (VIDEX EC Delayed-Release Capsules). Please consult the prescribing information for VIDEX EC (didanosine). The chemical name for didanosine is 2���,3���-dideoxyinosine. The structural formula is: Didanosine is a white crystalline powder with the molecular formula CHNOand a molecular weight of 236.2. The aqueous solubility of didanosine at 25��C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic solutions. For example, at pH<3 and 37��C, 10% of didanosine decomposes to hypoxanthine in less than 2 minutes.lld:dailymed
dailymed-drugs:3624dailymed-instance:clinicalP...Animal Toxicology: Evidence of a dose-limiting skeletal muscle toxicity has been observed in mice and rats (but not in dogs) following long-term (greater than 90 days) dosing with didanosine at doses that were approximately 1.2 to 12 times the estimated human exposure. The relationship of this finding to the potential of VIDEX (didanosine) to cause myopathy in humans is unclear. However, human myopathy has been associated with administration of VIDEX and other nucleosideanalogues.<br/>Pharmacokinetics: The pharmacokinetic parameters of didanosine are summarized in Table 1. Didanosine is rapidly absorbed, with peak plasma concentrations generally observed from 0.25 to 1.50 hours following oral dosing. Increases in plasma didanosine concentrations were dose proportional over the range of 50 to 400 mg. Steady-state pharmacokinetic parameters did not differ significantly from values obtained after a single dose. Binding of didanosine to plasma proteins in vitro was low (<5%). Based on data from in vitro and animal studies, it is presumed that the metabolism of didanosine in man occurs by the same pathways responsible for the elimination of endogenous purines. Effect of Food on Absorption of Didanosine: Didanosine peak plasma concentrations (C) and area under the plasma concentration time curve (AUC) were decreased by approximately 55% when VIDEX tablets were administered up to 2 hours after a meal. Administration of VIDEX tablets up to 30 minutes before a meal did not result in any significant changes in bioavailability. VIDEX should be taken on an empty stomach, at least 30 minutes before or 2 hours after eating. (See DOSAGE AND ADMINISTRATION.)<br/>Special Populations: Renal Insufficiency: It is recommended that the VIDEX (didanosine) dose be modified in patients with reduced creatinine clearance and in patients receiving maintenance hemodialysis (see DOSAGE AND ADMINISTRATION). Data from two studies in adults indicated that the apparent oral clearance of didanosine decreased and the terminal elimination half-life increased as creatinine clearance decreased (see Table 2). Following oral administration, didanosine was not detectable in peritoneal dialysate fluid (n=6); recovery in hemodialysate (n=5) ranged from 0.6% to 7.4% of the dose over a 3-4 hour dialysis period. The absolute bioavailability of didanosine was not affected in patients requiring dialysis. Pediatric Patients: The pharmacokinetics of didanosine have been evaluated in HIV-exposed and -infected pediatric patients from birth to 19 years of age (see Table 1). Overall, the pharmacokinetics of didanosine in pediatric patients are similar to those of didanosine in adults. Didanosine plasma concentrations appear to increase in proportion to oral doses ranging from 25 to 120 mg/min pediatric patients less than 5 months old and from 80 to 180 mg/min children above 8 months old. For information on controlled clinical studies in pediatric patients, see INDICATIONS AND USAGE: Clinical Studies and PRECAUTIONS: Pediatric Use. Geriatric Patients: Didanosine pharmacokinetics have not been studied in patients over 65 years of age. Gender: The effects of gender on didanosine pharmacokinetics have not been studied. Drug Interactions: Ribavirin has been shown in vitro to increase intracellular triphosphate levels of didanosine, which could cause or worsen clinical toxicities (see PRECAUTIONS: Drug Interactions). Tables 3 and 4 summarize the effects on AUC and C, with a 90% or 95% confidence interval (CI) when available, following coadministration of VIDEX (didanosine) with a variety of drugs. For most of the listed drugs, no clinically significant pharmacokinetic interactions were observed. Clinical recommendations based on drug interaction studies for drugs in bold font are included in PRECAUTIONS: Drug Interactions and DOSAGE AND ADMINISTRATION (for tenofovir).lld:dailymed
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dailymed-drugs:3624dailymed-instance:supplyVIDEX (didanosine) Pediatric Powder for Oral Solution is supplied in 4- and 8-ounce glass bottles containing 2 g or 4 g of VIDEX, respectively. The bottles of powder should be stored at 59��to 86��F (15��to 30��C). The VIDEX admixture may be stored up to 30 days in a refrigerator, 36��to 46��F (2��to 8��C). Discard any unused portion after 30 days. The NDC numbers for the previously described VIDEX products are: US Patent Nos: 4,861,759, 5,254,539, 5,616,566, and 5,880,106.lld:dailymed
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dailymed-drugs:3624dailymed-instance:boxedWarn...WARNING: FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS . 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, REPRODUCTION, AND FERTILITY).lld:dailymed
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dailymed-drugs:3624dailymed-instance:precautio...Frequency of Dosing: The preferred dosing frequency of VIDEX is twice daily because there is more evidence to support the effectiveness of this dosing frequency. Once-daily dosing should be considered only for adult patients whose management requires once-daily dosing of VIDEX (see INDICATIONS AND USAGE: Clinical Studies). VIDEX should be taken on an empty stomach, at least 30 minutes before or 2 hours after eating.<br/>Peripheral Neuropathy: Peripheral neuropathy, manifested by numbness, tingling, or pain in the hands or feet, has been reported in patients receiving VIDEX therapy. Peripheral neuropathy has occurred more frequently in patients with advanced HIV disease, in patients with a history of neuropathy, or in patients being treated with neurotoxic drug therapy, including stavudine. Peripheral neuropathy, which was severe in some cases, has been reported in HIV-infected patients receiving hydroxyurea in combination with antiretroviral agents, including didanosine, with or without stavudine (see ADVERSE REACTIONS).<br/>Fat Redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and���cushingoid appearance���have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.<br/>Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including VIDEX. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.<br/>General: Patients with Renal Impairment: Patients with renal impairment (creatinine clearance<60 mL/min) may be at greater risk of toxicity from VIDEX due to decreased drug clearance (see CLINICAL PHARMACOLOGY). A dose reduction is recommended in these patients . Hyperuricemia: VIDEX has been associated with asymptomatic hyperuricemia; treatment suspension may be necessary if clinical measures aimed at reducing uric acid levels fail.<br/>Information for Patients (see Patient Information Leaflet): Patients should be informed that a serious toxicity of VIDEX used alone and in combination regimens is pancreatitis, which may be fatal. Patients should be informed that the preferred dosing frequency of VIDEX is twice daily because there is more evidence to support the effectiveness of this dosing frequency. Once-daily dosing should be considered only for adult patients whose management requires once-daily dosing of VIDEX. Patients should also be aware that peripheral neuropathy, manifested by numbness, tingling, or pain in hands or feet, may develop during therapy with VIDEX. Patients should be counseled that peripheral neuropathy occurs with greatest frequency in patients with advanced HIV disease or a history of peripheral neuropathy, and that dose modification and/or discontinuation of VIDEX may be required if toxicity develops. Patients should be informed that when VIDEX is used in combination with other agents with similar toxicities, the incidence of adverse events may be higher than when VIDEX is used alone. These patients should be followed closely. Patients should be cautioned about the use of medications or other substances, including alcohol, that may exacerbate VIDEX toxicities. VIDEX (didanosine) is not a cure for HIV infection, and patients may continue to develop HIV-associated illnesses, including opportunistic infection. Therefore, patients should remain under the care of a physician when using VIDEX. Patients should be advised that VIDEX therapy has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Patients should be informed that the long-term effects of VIDEX are unknown at this time. Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time.<br/>Drug Interactions (see also CLINICAL PHARMACOLOGY: Drug Interactions): Drug interactions that have been established based on drug interaction studies are listed with the pharmacokinetic results in CLINICAL PHARMACOLOGY: Drug Interactions (Tables 3 and 4). The clinical recommendations based on the results of these studies are listed in Table 6. Coadministration of VIDEX with drugs that are known to cause pancreatitis may increase the risk of this toxicity (see WARNINGS: Pancreatitis). Because VIDEX is mixed with an antacid before administration, interactions may be anticipated with drugs whose absorption can be affected by the level of acidity in the stomach and with drugs that have been demonstratedto interact with antacids containing magnesium, calcium, or aluminum. Predicted drug interactions with VIDEX are listed in Table 7.<br/>Nucleoside/nucleotide analogues:<br/>Carcinogenesis and Mutagenesis: Lifetime carcinogenicity studies were conducted in mice and rats for 22 and 24 months, respectively. In the mouse study, initial doses of 120, 800, and 1200 mg/kg/day for each sex were lowered after 8 months to 120, 210, and 210 mg/kg/day for females and 120, 300, and 600 mg/kg/day for males. The two higher doses exceeded the maximally tolerated dose in females and the high dose exceeded the maximally tolerated dose in males. The low dose in females represented 0.68-fold maximum human exposure and the intermediate dose in males represented 1.7-fold maximum human exposure based on relative AUC comparisons. In the rat study, initial doses were 100, 250, and 1000 mg/kg/day, and the high dose was lowered to 500 mg/kg/day after 18 months. The upper dose in male and female rats represented 3-fold maximum human exposure. Didanosine induced no significant increase in neoplastic lesions in mice or rats at maximally tolerated doses. Didanosine was positive in the following genetic toxicology assays: 1) the Escherichia coli tester strain WP2 uvrA bacterial mutagenicity assay; 2) the L5178Y/TK+/- mouse lymphoma mammalian cell gene mutation assay; 3) the in vitro chromosomal aberrations assay in cultured human peripheral lymphocytes; 4) the in vitro chromosomal aberrations assay inChinese Hamster Lung cells; and 5) the BALB/c 3T3 in vitro transformation assay. No evidence of mutagenicity was observed in an Ames Salmonella bacterial mutagenicity assay or in rat and mouse in vivo micronucleus assays.<br/>Pregnancy, Reproduction, and Fertility: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 12 and 14.2 times the estimated human exposure (based upon plasma levels), respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to didanosine. At approximately 12 times the estimated human exposure, didanosine was slightly toxic to female rats and their pups during mid and late lactation. These rats showed reduced food intake and body weight gains but the physical and functional development of the offspring was not impaired and there were no major changes in the F2 generation. A study in rats showed that didanosine and/or its metabolites are transferred to the fetus through the placenta. Animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies of didanosine in pregnant women. Didanosine should be used during pregnancy only if the potential benefit justifies the potential risk. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis syndrome reported in nonpregnant individuals receiving nucleoside analogues (see WARNINGS: Lactic Acidosis/Severe Hepatomegaly with Steatosis). 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. Health care providers caring for HIV-infected pregnant women receiving didanosine should be alert for early diagnosis of lactic acidosis/hepatic steatosis syndrome. Antiretroviral Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to didanosine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.<br/>Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV. A study in rats showed that following oral administration, didanosine and/or its metabolites were excreted into the milk of lactating rats. It is not known if didanosine isexcreted in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving VIDEX.<br/>Pediatric Use: Use of VIDEX in pediatric patients from 2 weeks of age through adolescence is supported by evidence from adequate and well-controlled studies of VIDEX in adults and pediatric patients (see INDICATIONS AND USAGE: Clinical Studies, CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION). Dosing recommendations for VIDEX in patients less than 2 weeks of age cannot be made because the pharmacokinetics of didanosine in these children are too variable to determine an appropriate dose.<br/>Geriatric Use: In an Expanded Access Program for patients with advanced HIV infection, patients aged 65 years and older had a higher frequency of pancreatitis (10%) than younger patients (5%) . Clinical studies of didanosine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects. Didanosine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly (see DOSAGE AND ADMINISTRATION: Dose Adjustment).lld:dailymed
dailymed-drugs:3624dailymed-instance:overdosag...There is no known antidote for VIDEX (didanosine) overdosage. In phase 1 studies, in which VIDEX was initially administered at doses ten times the currently recommended dose, toxicities included: pancreatitis, peripheral neuropathy, diarrhea, hyperuricemia, and hepatic dysfunction. Didanosine is not dialyzable by peritoneal dialysis, although there is some clearance by hemodialysis .lld:dailymed
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dailymed-drugs:3624dailymed-instance:adverseRe...A SERIOUS TOXICITY OF VIDEX (didanosine) IS PANCREATITIS, WHICH MAY BE FATAL . OTHER IMPORTANT TOXICITIES INCLUDE LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS; RETINAL CHANGES AND OPTIC NEURITIS; AND PERIPHERAL NEUROPATHY . When VIDEX is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when VIDEX is used alone. Thus, patients treated with VIDEX in combination with stavudine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy . Adults: Selected clinical adverse events that occurred in adult patients in clinical studies with VIDEX are provided in Tables 8 and 9. Pancreatitis resulting in death was observed in one patient who received VIDEX (didanosine) plus stavudine plus nelfinavir in Study Al454-148 and in one patient who received VIDEX plus stavudine plus indinavir in the START 2 study. In addition, pancreatitis resulting in death was observed in 2 of 68 patients who received VIDEX plus stavudine plus indinavir plus hydroxyurea in an ACTG clinical trial . The frequency of pancreatitis is dose related. In phase 3 studies, incidence ranged from 1% to 10% with doses higher than are currently recommended and from 1% to 7% with recommended dose. Selected laboratory abnormalities in clinical studies with VIDEX are shown in Tables 10-12. Observed During Clinical Practice: The following events have been identified during postapproval use of VIDEX (didanosine). Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to VIDEX, or a combination of these factors. Pediatric Patients: In clinical trials, 743 pediatric patients between 2 weeks and 18 years of age have been treated with VIDEX. Adverse events and laboratory abnormalities reported to occur in these patients were generally consistent with the safety profile of didanosine in adults. In pediatric phase 1 studies, pancreatitis occurred in 2 of 60 (3%) patients treated at entry doses below 300 mg/m/day and in 5 of 38 (13%) patients treated at higher doses. In study ACTG 152, pancreatitis occurred in none of the 281 pediatric patients who received didanosine 120 mg/mq12h and in<1% of the 274 pediatric patients who received didanosine 90 mg/mq12h in combination with zidovudine (see INDICATIONS AND USAGE: Clinical Studies). Retinal changes and optic neuritis have been reported in pediatric patients.lld:dailymed
dailymed-drugs:3624dailymed-instance:indicatio...VIDEX (didanosine) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection (see Clinical Studies).<br/>Clinical Studies:<br/>Combination Therapy: START 2 was a multicenter, randomized, open-label study comparing VIDEX (200 mg twice daily)/stavudine/indinavir to zidovudine/lamivudine/indinavir in 205 treatment-naive patients. Both regimens resulted in a similar magnitude of suppression of HIV RNA levels and increases in CD4 cell counts through 48 weeks. Study A1454-148 was a randomized, open-label, multicenter study comparing treatment with VIDEX (400 mg once daily) plus stavudine (40 mg twice daily) and nelfinavir (750 mg three times daily) versus zidovudine (300 mg twice daily) plus lamivudine (150 mg twice daily) and nelfinavir (750 mg three times daily) in 756 treatment-naive patients, with a median CD4 cell count of 340 cells/mm(range 80 to 1568 cells/mm) and a median plasma HIV-1 RNA of 4.69 logcopies/mL (range 2.6 to 5.9 logcopies/mL) at baseline. Median CD4 cell count increases at 48 weeks were 188 cells/mmin both treatment groups. Treatment response and outcomes through 48 weeks are shown in Figure 1 and Table 5.<br/>Monotherapy: The efficacy of VIDEX was demonstrated in two randomized, double-blind studies comparing VIDEX, given on a twice-daily schedule, to zidovudine, given three times daily, in 617 (ACTG 116A, conducted 1989-1992) and 913 (ACTG 116B/117, conducted 1989-1991) patients with symptomatic HIV infection or AIDS who were treated for more than one year. In treatment-naive patients (ACTG 116A), the rate of HIV disease progression or death was similar between the treatment groups; mortality rates were 26% for patients receiving VIDEX and 21% for patients receiving zidovudine. Of the patients who had received previous zidovudine treatment (ACTG 116B/117), those treated with VIDEX had a lower rate of HIV disease progression or death (32%) compared to those treated with zidovudine (41%); however, survival rates were similar between the treatment groups. Efficacy in pediatric patients was demonstrated in a randomized, double-blind, controlled study (ACTG 152, conducted 1991-1995) involving 831 patients 3 months to 18 years of age treated for more than 1.5 years with zidovudine (180 mg/mq6h), VIDEX (120 mg/mq12h), or zidovudine (120 mg/mq6h) plus VIDEX (90 mg/mq12h). Patients treated with VIDEX or VIDEX plus zidovudine had lower rates of HIV disease progression or death compared with those treated with zidovudine alone. Studies have demonstrated that the clinical benefit of monotherapy with antiretrovirals, including VIDEX, was time limited.lld:dailymed
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