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Biomedical subjects

H Jaeger

Publications and source records attributed to H Jaeger.

At least 19 recordsLinked to original sources

Evaluation of quantitative parametric analysis for characterization of breast lesions in contrast-enhanced MR mammography.

Our aim was to evaluate quantitative parametric analysis for characterization of breast lesions in contrast-enhanced magnetic resonance (MR) mammography. In 62 patients, contrast-enhanced MR mammography revealed 75 suspicious lesions, of which 18 were benign and 57 were malignant. The quantitative parametric analysis delineates signal intensity changes of contrast-enhanced lesions on a pixel-by-pixel basis. The initial rate of enhancement is coded by color intensity: a slow rate is coded to dark; a fast rate, bright. The postinitial enhancement change is coded by color hue: blue for increasing signal intensity, green for plateau, and red for decrease in signal intensity. Malignant lesions showed a significantly higher number of bright-red (P = 0.004) and medium-red (P < 0.001) pixels than benign lesions. Benign lesions showed significantly more blue pixels than did malignant lesions (P = 0.010). Of the 75 lesions, 72 (96%) showed heterogeneous distribution of pixel color hue. Quantitative parametric analysis of contrast kinetics in lesions can replace the subjective manual region of interest (ROI) method and makes a step toward standardization of MR mammography. It allows quantitative evaluation of different contrast kinetics parameters in contrast-enhanced breast lesions.

Adult↗

[Angiographic follow-up after carotid artery stenting of bifurcation stenosis].

PURPOSE: The purpose of this prospective study was to determine the restenosis grade, the intima hyperplasia and the stent expansion via angiographic follow-up six months after carotid artery stenting. MATERIALS AND METHODS: In 100 patients, angiographic follow-up was performed 5.9 months (range: 2.9-11.4 months) after carotid artery stenting. The restenosis grade, the intima hyperplasia and the stent expansion were measured by selective angiography of the treated carotid artery. RESULTS: The mean restenosis grade was 16 % (range: 0-78 %). In 6 of 100 patients (6 %), a restenosis grade of > 50 % was measured. In 4 patients the restenosis grade was 50-70 %. In 2 patients the restenosis grade was > 70 %. In 91 of 100 patients (91 %), the restenosis was localized in the former area of stenosis of the carotid artery, and in 9 of 100 patients (9 %), the restenosis was localized in the cranial stent end. The mean grade of intima hyperplasia was 31 % (range: 2-70 %). The mean increase in stent expansion at the time of follow-up was 10 % (range: 0-59 %). No correlation was able to be determined between the grade of stenosis and the grade of restenosis (rho = 0.017, range: - 0.180-0.213), between the grade of residual stenosis and the grade of restenosis (rho = 0.257, range: 0.064-0.431) and between intima hyperplasia and the grade of restenosis (rho = 0.476, range: 0.309-0.615). CONCLUSIONS: Carotid artery stenting is associated with a low incidence of high-grade restenosis 6 months after an intervention. The intima hyperplasia, which can be observed in each Wallstent, is partly compensated by the expansion of the self-expandable stent. Without a correlation between the grade of residual stenosis and the grade of restenosis, low-grade residual stenosis can be accepted. Therefore, we recommend undersized postdilation of the Wallstent.

Aged↗

Long-term consequences of treatment interruptions in chronically HIV-1-infected patients.

OBJECTIVE: To evaluate the long-term effects of antiretroviral treatment (ART) interruptions on metabolic, immunological, virological and clinical outcomes in chronically HIV-1 infected patients. METHODS: Multi-centric, prospective, controlled 24-month cohort study in HIV-1 infected patients interrupting ART once or several times and for at least two weeks. Patients were compared to a frequency-matched control group continuing on ART. RESULTS: A total of 399 HIV-1 infected patients were included, among them 133 patients with treatment interruption (TI) and 266 control patients. Baseline characteristics were well matched. Median baseline CD4 cell count was 379/microl in TI-patients and 410/microl in control patients (p = ns). Median duration of the first TI was 1.1 months, and 37 % of patients had two or further TI's. Whereas CD4 cell count in control patients had increased significantly by a median of 67/microl at month 24 (p<0.0001), median CD4 cell count at month 24 in the TI-patients did not differ significantly from baseline. However, two-year AIDS-free survival was not significantly different between TI- and control patients. Liver enzymes and blood lipids improved significantly during TI. CONCLUSION: TI was associated with a significant immunological disadvantage at 24-month follow-up compared to continued ART. In this relatively immunocompetent cohort, however, TI's did not lead to an increased risk of disease progression within two years of follow-up.

Adult↗

A prospective, controlled study assessing the effect of lopinavir on amprenavir concentrations boosted by ritonavir.

In a controlled, prospective study, the efficacy of ritonavir 200 mg twice daily (bid) in inhibiting the decrease of amprenavir plasma concentrations caused by co-administration of lopinavir was assessed. Twelve HIV-seropositive patients were enrolled, and nine patients completed the 28-day study. At day 14, plasma concentrations of amprenavir 600 mg bid and ritonavir 200 mg bid were determined over 12 h. At day 15, lopinavir 400 mg bid was added. At day 28, plasma concentrations of amprenavir, ritonavir and lopinavir were assessed. Co-administration of lopinavir was found to decrease the amprenavir concentration, determined as the median area under the curve over 12 h (AUC12), by 25% (AUC12 24.9 microg/h/mL vs. 18.5 microg/h/mL; P<0.01), despite the presence of ritonavir 200 mg bid. Eight participants discontinued the study regimen during the first 6 weeks because of adverse gastrointestinal events. In conclusion, gastrointestinal tolerance of a regimen containing an increased dose of ritonavir 200 mg bid was low, while the regimen did not prevent a decrease of amprenavir and possibly lopinavir plasma concentrations.

Anti-HIV Agents↗

Risk factors for the HIV-associated lipodystrophy syndrome in a closed cohort of patients after 3 years of antiretroviral treatment.

OBJECTIVE: To identify prevalence and risk factors associated with the HIV-associated lipodystrophy syndrome (HIVLD) after 3 years of antiretroviral therapy, to investigate the diagnostic value of anthropometric measures and to assess the impact of HIVLD on quality of life. DESIGN AND METHODS: A prospective, cross-sectional, multicentre, observational, cohort study was performed in 27 German teaching hospitals, nonacademic hospitals and private practices. A total of 221 HIV-positive patients commencing antiretroviral therapy between July and September 1996 were studied. The main outcome measure was lipodystrophy, defined as otherwise unexplained truncal fat accumulation and/or fat loss in face or extremities. The analysis consisted of multiple logistic regression models, receiver operating characteristics (ROC) curves for anthropometric measures and visual analogue scales for quality of life. RESULTS: The prevalence of HIVLD after 3 years was 34%. The following variables were independently associated with HIV-LS: stavudine use > 12 months [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.1-3.9], CD4 count nadir < 200 cells/microL (OR 2.2, CI 1.1-4.6), hypertriglyceridaemia (OR 2.3, CI 1.3-4.2) and nonnucleoside reverse transcriptase inhibitor (NNRTI) intake > 12 months (OR 0.2, CI 0.04-0.87). No cut-off point was found for anthropometric indices with a sensitivity and specificity of > or = 0.8. The mean visual analogue ratings for impaired quality of life, on a scale of 0-10, were: 5.2 (self-esteem), 2.9 (social contacts), 4.2 (sexuality) and 3.5 (daily activities). CONCLUSIONS: These findings suggest a multifactorial aetiology for HIVLD. Stavudine use and a CD4 count below 200 cells/microL may be associated with an increased risk for the development of HIVLD. In contrast, NNRTI treatment may be associated with a reduced risk. Anthropometric indices were found to be insufficient as a diagnostic tool. Quality of life was severely affected by HIVLD.

Adult↗

Cardiology and AIDS--HAART and the consequences.

Since the introduction of highly active antiretroviral therapy (HAART), AIDS has become a treatable disease. A steep decline in morbidity and mortality has been observed in most western countries. The HIV epidemic is now moving into middle-aged populations which are already at increased risk for cardiovascular disease. Since the cardiovascular system is frequently affected in HIV infection, reflections on traditional cardiovascular risk factors is a pressing issue. Moreover, during the last few years, complex lipodystrophic body changes in association with metabolic abnormalities such as dyslipidemia and insulin resistance have become a common feature in HIV+ patients on HAART. Although the precise mechanisms are not fully understood, early reports on myocardial infarctions and vascular changes have raised concern about the possibility of an epidemic of cardiovascular events among HAART patients within the next decade. Not only more data on lipid-lowering drugs in the context of HAART, on switching strategies, and treatment interruptions, but also from intervention studies on traditional risk factors such as smoking, are urgently needed. In this review the key issues concerning cardiovascular aspects of HIV infection in the era of HAART and possible preventive strategies are discussed.

Acquired Immunodeficiency Syndrome↗

Intracellular supply of phospholipids for biliary secretion: evidence for a nonvesicular transport component.

Phospholipids (PL) for biliary secretion could be supplied from the endoplasmic reticulum (ER) to the plasma membrane by cytosolic transfer proteins or transport vesicles. Therefore, we studied whether biliary secretions of PL and apolipoprotein A-I (apo A-I), as markers for the ER-to-Golgi vesicular transport pathway, are tightly coupled in isolated perfused rat livers with enhanced secretion (+60%) of PL after withdrawal of the cholesterol synthesis inhibitor pravastatin (0.1% of chow, fed for 7 days). Blocking agents dissociated the secretion of apo A-I and PL. Brefeldin A as well as cycloheximide inhibited biliary secretion of apo A-I (-52%; -68%), however, not of PL. Both bilirubin ditaurate and taurodehydrocholic acid reduced biliary secretion of PL (-27%; -79%), but not of apo A-I. The data support the concept that PL destined for biliary secretion bypass the vesicular transport pathway of apo A-I through the Golgi compartment, most likely via cytosolic transfer proteins.

Animals↗

Observable operator models for discrete stochastic time series.

A widely used class of models for stochastic systems is hidden Markov models. Systems that can be modeled by hidden Markov models are a proper subclass of linearly dependent processes, a class of stochastic systems known from mathematical investigations carried out over the past four decades. This article provides a novel, simple characterization of linearly dependent processes, called observable operator models. The mathematical properties of observable operator models lead to a constructive learning algorithm for the identification of linearly dependent processes. The core of the algorithm has a time complexity of O(N + nm3), where N is the size of training data, n is the number of distinguishable outcomes of observations, and m is model state-space dimension.

Linear Models↗

Evaluation of the pharmacokinetics and absolute bioavailability of three isosorbide-5-mononitrate preparations in healthy volunteers.

The objective of this study was two-fold: 1. to determine the pharmacokinetic parameters and the bioavailability of two 20 mg isosorbide-5-mononitrate (CAS 16051-77-7, IS-5-MN) preparations (treatments A and B) after single oral administration and 2. to evaluate the absolute bioavailability of IS-5-MN, which was possible by the administration of a third IS-5-MN preparation (treatment C) by the intravenous route (1 mg/ml, dose 20 mg). The three preparations were examined in 24 healthy volunteers according to a randomized 3-way cross-over design, blood samples were withdrawn up to 24 h following the administration of IS-5-MN and plasma concentrations of IS-5-MN were quantified by a gas chromatography method. The two oral preparations led to peak concentration values of about 360 ng/ml of IS-5-MN in the mean 0.90 h (treatment A) and 0.97 h (treatment B) after drug administration. The corresponding values for the infusion were 339.6 ng/ml and 2.59 h in the mean. For the areas under the curve (AUC(0-infinity)) mean values of 2733 (treatment A). 2724 (treatment B) and 2877 h x ng/ml (treatment C) were found. The absolute bioavailability of both oral treatments revealed values of 95.00% and 94.74% for treatments A and B, respectively. The statistical comparison (ANOVA, confidence intervals) of the pharmacokinetic parameters showed bioequivalence between both oral preparations and equivalence in the amount of drug absorption between both oral formulations and the i.v.-infusion. The observed undesired side effects (e.g. headache or nausea) are well known to occur after IS-5-MN administration.

Administration, Oral↗

[The pharmacokinetics and bioavailability of a new mexiletine preparation in healthy volunteers].

In the course of this study, both the bioavailability and the most important pharmacokinetic parameters of a newly development mexiletine (CAS 31828-71-4) preparation (Mexiletine-ratiopharm mite, dosage 200 mg of mexiletine) were to be determined in comparison to a commercial reference preparation registered according to the AMG 1976, after single oral administration. For this purpose, the test and the reference preparation were examined in healthy male volunteers according to a randomized, 2-way crossover design. Both preparations entrained maximum plasma levels of approx. 300 ng/ml 3.5-4 h following administration. For the areas under the curve, values around 4000 h x ng/ml were found; the plasma half-life of the test preparation was 7.55, for the reference preparation 7.75 h. The statistical comparison (ANOVA, confidence interval according to Westlake, Pratt-Wilcoxon-Test) of the pharmacokinetic parameters obtained in the study clearly resulted in bioequivalence of the newly developed mexiletine preparation and the reference drug. No side effects worth mentioning were observed after administration of either preparation, thus good and comparable clinical tolerability of both preparations may be presumed.

Adolescent↗

[Postoperative warming therapy in the recovery room. A comparison of radiative and convective warmers].

Hypothermia (Tcore < 36 degrees C) can be observed in 60%-80% of all admissions to the post-anaesthetic recovery unit. Effective warming devices may accelerate rewarming, improve patient comfort, and suppress shivering thermogenesis. This study was designed to compare the efficiency of warming devices in extubated postoperative patients and their effect on postoperative oxygen uptake (VO2). METHODS. Thirty-five ASA I and II patients after laparoscopic hernioplastic repair with core temperatures < 36 degrees C were randomly assigned to either postoperative nursing under a radiant heater (group R, n = 11, Aragona Thermal Ceilings CTC X, Aragona Medical AB, Täby, Sweden), a forced air system (group L, n = 12, Bair Hugger, Augustine Medical Inc., Eden Prairie, Minnesota, USA), or a normal cotton hospital blanket (group K, n = 12). Anaesthesia was conducted totally intravenously with propofol, alfentanil, and vecuronium. Mean body temperature and total body heat were calculated from urinary bladder temperature and four subcutaneous temperature measurements. The rate of thermogenesis was calculated from continuous measurement of VO2 (Datex Deltatrac Metabolic Monitor, Datex Instrumentarium Corp., Helsinki, Finland). Heat balance was derived from the increase in total body heat minus body heat production. Heart rate and noninvasive blood pressure were measured by the Cardiocap (Datex Instrumentarium Corp., Helsinki, Finland). All data were transferred to an IBM-compatible computer at 60-s intervals. Measurements were stopped when core temperature reached 37 degrees C. The rate of change was calculated for each variable for the period 15 min after the beginning of rewarming to attainment of 37 degrees C. Data are presented as median, minima, and maxima (min<==>max); the Mann-Whitney U test was used to test for significance of group differences. RESULTS. All groups were comparable for body weight, height, age, and amount of postoperative infusions. Temperatures at admission were 35.2 (33.4<==>35.9), 34.7 (34.3<==>35.8), and 35.4 (34.3<==>35.9) degrees C for groups R, B, and K, respectively. No significant differences in the rate of central rewarming could be found for these groups with 0.81 (0.41<==>1.32), 0.76 (0.40<==>1.07), and 0.70 (0.37<==>1.13) degrees C/h (Fig. 1). The mean VO2 of 3.41 (3.07<==>3.73), 3.55 (2.78<==>4.06), and 3.79 (2.51<==>7.00) ml/kg/min also did not differ significantly (Fig. 3). Significant differences between groups R and B [4.39 (3.74<==>6.19) and 4.30 (3.46<==>6.67) ml/kg/min] and K [5.92 (3.79<==>10.64) ml/kg/min] were found for VO2 maxima during the course of investigation (Fig. 4). The heat balance revealed significant differences among treatment and control groups with -88 (-226<==>+30), -41 (-212<==>+12), and -191 (-265<==>-86) kJ/h for groups R, B, and K. We additionally calculated the heat balance as a quotient, which showed 0.70 (0.22<==>1.07), 0.86 (0.44<==>1.04), and 0.49 (0.31<==>0.79) for groups R, B, and K (Fig. 4). The mean rate-pressure product of all groups did not differ significantly during the period of investigation. CONCLUSIONS. Neither external heat supply by radiant heat nor by a forced warm air system significantly reduced rewarming time in extubated, awake patients. As measured by heat balance, both active treatments saved about 20% more body heat production than in the control group. Continuing peripheral vasoconstriction may be the reason for the low efficiency of heat transfer. Thermal treatment did reduce the peak load (max. VO2) on the oxygen transport systems, though shivering was treated by pethidine if it occurred. External rewarming did not reduce the average load (mean VO2). Thus, concerning the goal of accelerating rewarming, it appears more rational to prevent intraoperative heat loss. For a comparison of efficiency of different warming devices, postoperative extubated patients do not appear to be an ideal model for study.

Adult↗

Construction of shuttle plasmids which can be efficiently mobilized from Escherichia coli into the chromatically adapting cyanobacterium, Fremyella diplosiphon.

In some strains of cyanobacteria the composition of the light-harvesting antennae is determined by the color of available light. The mechanism of this chromatic adaptation involves the regulation of gene expression by red and green light and has been most studied in Fremyella diplosiphon (Calothrix sp. PCC 7601), a filamentous cyanobacterium for which there has been no reported means of genetic manipulation. We have constructed shuttle plasmids which can be efficiently mobilized by RP4 from Escherichia coli into F. diplosiphon and which can be recovered from transconjugant F. diplosiphon and returned to E. coli by transformation. The ability of these plasmids to replicate in F. diplosiphon is conferred by an 8.0-kb DNA fragment isolated from pFDA, a plasmid native to F. diplosiphon. To create these shuttle plasmids the 8.0-kb fragment was cloned into pJCF22, a mobilizable plasmid constructed from oriV and bom from pBR322, cat from pACYC184 and aphA from pACYC177.pJCF22 lacks sites for the restriction enzymes FdiI and II. Transconjugant F. diplosiphon containing shuttle plasmid pJCF62 are resistant to chloramphenicol and highly resistant to the aminoglycosides, G418 and neomycin. When aadA from the omega interposon was incorporated into a shuttle plasmid transconjugant F. diplosiphon could also be selected with streptomycin or spectinomycin. In F. diplosiphon shuttle plasmid pJCF62 replicates with a minimum copy number of seven. The oriV for replication in F. diplosiphon was localized to a 2.8-kb region within the cyanobacterial part of pJCF62. The presence on a shuttle plasmid of a single recognition site for FdiI reduced the efficiency of mobilization into F. diplosiphon by 5- to 10-fold. Restriction at this site was prevented when the E. coli donor strain in the mating contained the enzyme Eco47II methylase.

Conjugation, Genetic↗

[The neuropathy of the autonomic nervous system. An additional anesthetic risk in diabetes mellitus].

Some 20-40% of diabetics suffer from an autonomic neuropathy. This complication of diabetes mellitus impairs the regulation and the reflexes of the cardiovascular system. This study compares the cardiovascular characteristics of diabetics and nondiabetic control patients. METHODS. 21 patients (11 diabetics, 10 nondiabetics) undergoing ophthalmic surgery were investigated. They were tested preoperatively for autonomic cardiovascular dysfunction by application of four established tests. These were: heart rate responses to the Valsalva maneuver, deep breathing and standing up (30/15 test) and the Schellong test. The anaesthesia was induced with fentanyl (0.1 mg), etomidate (2.5 mg/kg) and succinyl choline (1.5 mg) and maintained with oxygen/nitrous oxide (1.4:3 l/min) and isoflurane (0.2-0.8 vol%). Blood pressure and heart rate were automatically measured every minute during induction of anaesthesia and every 3 min during anaesthesia. Additionally the heart rate response to 0.5 mg atropine i.v. was evaluated. RESULTS. The autonomic function tests revealed pathologic reactions in all diabetics (two early, six definitive, three severe) and none in controls. Remarkable cardiovascular events occurred exclusively in the diabetic group, especially during induction of anaesthesia. The systolic blood pressure (SAP) increased in diabetics from a preinduction value of 150 mmHg (median, range 105-205 mmHg) to a maximum of 200 mmHg (160-250 mmHg) after intubation, in controls from 130 (100-150 mmHg) to 170 (110-190 mmHg). Following this peak, SAP fell in diabetics to 120 mmHg (80-160 mmHg), in controls to 110 (100-140 mmHg). Two diabetics had to be treated because of an SAP exceeding 220 mmHg, two other diabetics because of an SAP below 80 mmHg. After atropine administration the heart rate of diabetics showed a median increase of 15% (range 0-40%). In four diabetics, however, the increase was less than 10%. In control patients the increase was 50% (40-80%). All patients with severe cardiovascular reactions during induction of anaesthesia and with heart rate elevation following atropine of less than 10% had a definite or severe neuropathy of the autonomic nervous system revealed by the tests. DISCUSSION. In the only slightly stressful ophthalmic surgery, remarkable events were noted particularly during the induction of anaesthesia. The critical decreases and increases of SAP might be related to the autonomic dysfunction, because of the hypersensitivity of a partly damaged autonomic nervous system or its impaired function. This led to a loss of heart rate variation and adequate blood vessel tone. The severe cardiovascular reactions always went along with clearly pathologic findings in the tests performed. Normal test results in diabetics implied normal cardiovascular reactions, as could be observed in nondiabetics. CONCLUSION. Abnormal cardiovascular reactions in diabetics must be kept in mind. The simple tests specified here can identify such predisposed patients.

Adult↗

Evaluation of pharmacokinetics, bioavailability and dose linearity of diltiazem in healthy volunteers.

The objective of this randomized five-way cross-over study with healthy male volunteers was to determine, one the one hand, the bioavailability and main pharmacokinetic parameters of 4 sustained release diltiazem (Surecaps, CAS 42399-41-7) test preparations with ascending doses (180, 240, 300, 360 mg), administered as single application, versus an immediate release 60 mg diltiazem reference preparation, which was given thrice a day at 8-h intervals. On the other hand, the study also allowed the evaluation of a possible dose linearity of the test substance diltiazem. Plasma concentrations of diltiazem and its major metabolite desacetyl-diltiazem were measured by high pressure liquid chromatography (HPLC) up to 48 h after single dosing of the sustained release preparations as well as after repeated doses of the immediate release formulation. The undesired side effects/concomitant symptoms observed are known to occur after diltiazem administration. For the area under the curve, e.g. calculated from time 0 to the last quantifiable sample (AUC0-Tlast), the study revealed for the parent compound diltiazem mean values of 926.2, 1602.4, 1873.2 and 2415.7 h.ng/ml after administration of the 4 sustained release test preparations, respectively; for the immediate release reference preparation the value was 1007.2 h.ng/ml. Concerning the main metabolite desacetyl-diltiazem the corresponding values for the 4 sustained release formulations were 138.6, 236.9, 280.2 and 345.6 h.ng/ml, respectively. The corresponding value for the immediately release formulation was 127.5 h.ng/ml. Concerning a possible dose linearity of diltiazem, statistical analysis revealed a convincing linear relationship between at least 3 of the 4 sustained release preparations, therefore linearity may be assumed between 240 and 360 mg.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Low-dose oral natural human interferon-alpha in 29 patients with HIV-1 infection: a double-blind, randomized, placebo-controlled trial.

OBJECTIVE: To evaluate clinical efficacy and toxicity of low-dose oral natural human interferon-alpha (nHuIFN alpha) on CD4+ lymphocyte counts and clinical symptoms in patients with HIV-1 infection. DESIGN: Double-blind, randomized, placebo-controlled trial with crossover. SETTING: Private practice specializing in the treatment of patients with AIDS. PATIENTS, PARTICIPANTS: Only patients with HIV-1 infection and CD4+ lymphocyte counts between 200 and 500 x 10(6)/l were included for study. Thirty out of thirty-one patients at study entry completed treatment with placebo, and 29 completed nHuIFN alpha treatment. Mean patient age was 36 years (range, 25-58 years). The 30 patients included 26 men, of whom 22 were homosexual, and four women; five were drug users and none were currently on zidovudine therapy, although three had been previously. INTERVENTIONS: Patients were randomly assigned to cohorts of 10 to receive either 200 IU nHuIFN alpha once daily orally absorbed or placebo with crossover after 6 weeks. MAIN OUTCOME MEASURES: Every 2 weeks, a detailed history, physical examination, and laboratory tests, including CD4+ and CD8+ lymphocyte counts, were conducted. RESULTS: There was only a slight, transient increase in mean CD4+ lymphocyte counts after 4 weeks of treatment with nHuIFN alpha, compared with a slight decline when placebo was administered. This effect reached statistical significance in a subgroup of patients only and was not sustained after 6 weeks. There were no significant changes in weight and clinical symptoms. All patients remained HIV-1-antibody-positive. Treatment-related adverse reactions were not observed. CONCLUSIONS: Our double-blind, randomized, placebo-controlled clinical trial did not confirm a previous report of efficiency of oral nHuIFN alpha. Although non-toxic, our data do not justify the widespread use of low-dose oral nHuIFN alpha in HIV-infected patients outside controlled clinical trials.

Administration, Oral↗