Early switch from intravenous to oral cephalosporins in the treatment of hospitalized patients with community-acquired pneumonia

BACKGROUND: Switch therapy is defined as the early transition from intravenous to oral antibiotics during treatment of infection. This study was designed to evaluate the clinical outcome and length of stay of hospitalized patients with community-acquired pneumonia treated with an early switch from intravenous to oral third-generation cephalosporins. METHODS: Patients with a new roentgenographic pulmonary infiltrate and at least two symptoms (cough, fever, or leukocytosis) were enrolled in this study and treated with intravenous ceftizoxime sodium (1 g every 12 hours) or ceftriaxone sodium (1 g every 24 hours). Patients were switched to oral cefixime (400 mg every 24 hours) as soon as they met the following criteria: (1) resolution of fever; (2) improvement of cough and respiratory distress; (3) improvement of leukocytosis; and (4) presence of normal gastrointestinal tract absorption. RESULTS: Of the 120 patients enrolled, 75 (62%) had clinical data evaluated. Long-term follow-up showed that 74 patients (99%) were cured; one patient required readmission for further intravenous therapy. Mean duration of hospital stay was 4 days. CONCLUSIONS: This investigation demonstrated that an early switch to oral cefixime may be reasonable in hospitalized patients with community-acquired pneumonia who have already shown a good clinical and laboratory response to therapy with intravenous third-generation cephalosporins. This approach is clinically effective and minimizes hospital stay.     

An in vitro biocompatibility evaluation of double-J stents

This double-blind, randomized, multicenter trial compared clindamycin/primaquine (Cm/Prq) with trimethoprim-sulfamethoxazole (TMP-SMZ) as therapy for AIDS-related Pneumocystis carinii pneumonia (PCP). Forty-five patients received clindamycin (450 mg four times daily [q.i.d.]) and primaquine (15 mg of base/d); 42 received TMP-SMZ (320 mg/1,600 mg q.i.d. if weight of > or = 60 kg or 240 mg/1,200 mg q.i.d. if weight of < 60 kg) plus placebo primaquine. Overall, the efficacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 76% vs. 79%, respectively); Cm/Prq was associated with fewer adverse events (P = .04), less steroid use (P = .18), and more rashes (P = .07). These differences were even greater for patients with PaO2 of > 70 mm Hg (P = .02, P = .04, and P = .02, respectively). For patients with PaO2 of < or = 70 mm Hg (23 Cm/Prq recipients and 21 TMP-SMZ recipients), the efficacy of Cm/Prq was similar to that of TMP-SMZ (success rate, 74% vs. 76%, respectively); Cm/Prq was associated with similar adverse events (P = .57), steroid use (P = .74), and rashes (P = .78). This trial confirms that Cm/Prq is a reasonable alternative therapy for mild and moderately severe PCP.     

Protein binding of clindamycin in sera of patients with AIDS

Patients with AIDS have altered pharmacokinetics of clindamycin compared with those of healthy control subjects. In an attempt to better understand these differences, we undertook a study of protein binding of clindamycin in sera of patients with AIDS. Fifteen patients with AIDS and 15 healthy volunteers were given a single 600-mg dose of clindamycin orally and intravenously, and serum samples were collected at three time points corresponding to high, midpoint, and low clindamycin concentrations. Protein binding was determined by ultrafiltration, and total and unbound clindamycin concentrations were measured with a gas chromatography assay. AIDS patients had alpha 1-acid glycoprotein values approximately twice those of healthy volunteers (mean +/- standard deviation, 103 +/- 27 versus 61 +/- 11 mg/dl; P = 0.001). Overall, serum protein binding levels were higher in AIDS patients (mean +/- standard deviation, 83 +/- 7 versus 78% +/- 8%; P = 0.0001), which is likely the result of increased alpha 1-acid glycoprotein levels in these patients. Total concentrations of clindamycin in plasma were significantly higher in AIDS patients at most time points studied, while unbound serum clindamycin concentrations did not differ among the groups at each sampling time after both oral and intravenous dosing. Increased protein binding may partly explain the altered pharmacokinetic disposition of clindamycin in AIDS patients; however, other factors cannot be excluded.     

Atypical Pneumocystis carinii infection in AIDS: massive cervical lymphadenitis and fever of unknown origin

Pulmonary Pneumocystis carinii infections are relatively common in patients with the acquired immunodeficiency syndrome (AIDS). Extrapulmonary pneumocystis is a less common manifestation, particularly when it occurs without concurrent Pneumocystis carinii pneumonia. Disseminated pneumocystis is most commonly found in lymph nodes, the liver, and the spleen and may result in nonspecific debilitating illness, which is often overlooked in the absence of pulmonary symptoms. We present the case of an AIDS patient who had massive cervical pneumocystis lymphadenitis and minimal pulmonary infiltrates of undetermined etiology and a clinical picture of severe wasting and fever of unknown origin.     

Cytarabine therapy for progressive multifocal leukoencephalopathy in patients with AIDS

To evaluate the efficacy and safety of intravenous cytarabine in the treatment of AIDS-associated progressive multifocal leukoencephalopathy (PML), we reviewed the charts of all human immunodeficiency virus-infected patients with PML who were seen during a 28-month period at our institution. Patients with biopsy-proven PML were offered therapy with intravenous cytarabine (2 mg/[kg.d] for 5 days every 4 weeks). The diagnosis of PML was histologically confirmed for 13 patients. The median CD4 cell count was 91 x 10(6)/L. A median of three courses of cytarabine was administered to eight patients. Two patients developed mild drug-related toxicities. Clinical and/or radiological signs of improvement were observed for three patients treated with cytarabine; no signs of improvement were noted for the untreated patients. Median survival time after the diagnosis of PML was 102 days (range, 46-220 days) for patients who received cytarabine and 60 days (range, 28-72 days) for untreated patients matched for Karnofsky scores (P = .06, logrank test). Although cytarabine is well tolerated by patients with AIDS and PML, only modest short-term clinical improvement in the conditions of patients treated with the drug has been observed, with no significant impact on survival.     

Prevention of nausea and vomiting with granisetron, droperidol and metoclopramide during and after spinal anaesthesia for caesarean section: a randomized, double-blind, placebo-controlled trial

OBJECTIVE: To compare the safety and efficacy of a combination of amoxicillin and clavulanate potassium given orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) with that given every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for the treatment of patients with acute bacterial maxillary sinusitis. DESIGN: Multicenter double-blind randomized double-dummy controlled trial. SETTING: Physicians' offices and ambulatory care clinics. PATIENTS: One hundred seventy patients at least 18 years of age with acute bacterial maxillary sinusitis who could be treated with an oral antimicrobial agent were randomized, and data from 134 were suitable for evaluation. Four patients were withdrawn from this study because of adverse effects. INTERVENTIONS: Patients received a combination of amoxicillin and clavulanate orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) or every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for 14 days. MAIN OUTCOME MEASURE: Clinical success at the end of therapy. RESULTS: Clinical success at the end of therapy was similar for the 2 treatment groups, 93% and 88% of patients in the every 12-hour and every 8-hour groups, respectively (P = .76; 95% confidence interval, -4.0% to 15.6%). Clinical success rates at follow-up 2 to 4 weeks after the end of therapy were also similar in the 2 groups. Adverse events related to treatment were reported with similar frequency in the 2 groups. CONCLUSION: Amoxicillin and clavulanate given every 12 hours is as effective and as safe as administration every 8 hours for the treatment of acute bacterial maxillary sinusitis.     

Stepwise therapy of community-acquired pneumonia. Results of cefuroxime and cefuroxime axetil study

The efficacy of a 7-day switch therapy with parenteral cefuroxime in a dose of 750 mg for 3-5 days followed by the use of oral cefuroxime axetil in a dose of 500 mg every 12 hours was compared with that of a 7-day therapy with parenteral cefuroxime in a dose of 750 mg every 8 hours in hospitalized patients with community-acquired pneumonia. The clinical and bacteriological efficacies and pharmacokinetic properties of both the dosage forms were estimated. It was shown that the clinical and bacteriological effects did not significantly differ in the patients under the parenteral regimen with cefuroxime and under the parenteral-to-oral regimen with cefuroxime and cefuroxime axetil: the cure in 75 and 83 per cent of the patients and the bacteriological response in 100 and 86 per cent of the cases respectively. The results indicated that the cost of the switch therapy was much lower while the efficacy did not decrease.     

Acute dentoalveolar infections: an investigation of the duration of antibiotic therapy

OBJECTIVE: To evaluate shortened courses of antibiotics in the management of dentoalveolar abscesses. DESIGN: Prospective clinical study over a 3-year period. SETTING: Examinations department of the Liverpool University Dental Hospital. SUBJECTS: 759 patients, with acute dentoalveolar abscesses associated with swelling, and an elevation of axillary temperature to above 38.5 degrees C, were included in the investigation. The minimum age of the patients was 16 years. INTERVENTIONS: The initial treatment was to drain the abscess by incision (124 patients), or extraction (635). The patients were prescribed amoxycillin (250 mg every 8 hours), clindamycin (150 mg every 6 hours) or erythromycin stearate (250 mg every 6 hours) and instructed to drink plenty of fluid. All the patients were seen 2 or 3 and 10 days later; only patients who were seen at these times were included in the trial. MAIN OUTCOME MEASURES: Resolution of the swelling and a normal axillary temperature. RESULTS: At first review 748 patients (98.6%) had normal temperatures, marked resolution of the swelling and the antibiotic was discontinued. None of these 748 patients required further antibiotic therapy. CONCLUSIONS: The duration of antibiotic therapy in most patients with acute dentoalveolar infections can safely be 2-3 days, provided that drainage has been established. It is not, therefore, necessary for the majority of patients to complete a 5-day course of antibiotics.     

Pyrimethamine-clindamycin vs. pyrimethamine-sulfadiazine as acute and long-term therapy for toxoplasmic encephalitis in patients with AIDS

This European multicenter study compares the efficacy and tolerance of the combination of pyrimethamine-clindamycin (Pyr-Cm) with the standard therapy pyrimethamine-sulfadiazine (Pyr-Sdz) for the treatment of toxoplasmic encephalitis (TE) in patients with AIDS. Two hundred ninety-nine human immunodeficiency virus-infected patients with TE were randomly assigned to receive 50 mg of pyrimethamine daily combined with either 2,400 mg of clindamycin or 4 g of sulfadiazine for 6 weeks followed by maintenance therapy with 25 mg of pyrimethamine daily with either 1,200 mg of clindamycin or 2 g of sulfadiazine. An intent-to-treat analysis showed that Pyr-Cm was less effective than Pyr-Sdz; the overall risk of progression of TE was 1.84 times higher for patients receiving Pyr-Cm therapy. There was no statistically significant difference in efficacy during acute therapy, although the rate of crossover motivated by a lack of response was higher among Pyr-Cm recipients. The difference in efficacy was evidenced during the maintenance phase of treatment; the relapse rate was twice as high among patients in the Pyr-Cm group (P = .02). The rate of side effects due to both regimens was similar, although the toxic effects of Pyr-Cm led to fewer discontinuations of therapy than did those of Pyr-Sdz (11% vs. 30%, respectively; P = .001). Pyr-Sdz appears to be the most effective treatment of TE. Pyr-Cm is a valuable alternative but is less effective for long-term prevention of relapses.     

Clindamycin/primaquine as prophylaxis for Pneumocystis carinii pneumonia

The records of 206 patients with advanced infection due to human immunodeficiency virus type 1 who were receiving prophylaxis with clindamycin/primaquine (C/P), trimethoprim-sulfamethoxazole (TMP-SMZ), or dapsone to prevent Pneumocystis carinii pneumonia (PCP) were retrospectively examined. Two hundred sixty-two patient-years of prophylaxis were accrued (176.2 of TMP-SMZ, 63.4 of dapsone, and 22.8 of C/P). The rates of PCP in the TMP-SMZ, dapsone, and C/P groups were 3.4, 11.0, and 30.7 per 100 patient-years, respectively. Pairwise comparisons showed C/P to be less effective than TMP-SMZ (relative risk [RR], 9.02; 95% confidence interval [CI], 3.03-26.83). A similar trend was apparent for C/P vs. dapsone (RR, 2.78; 95% CI, 0.98-7.93). When only those receiving primary prophylaxis were analyzed, C/P recipients remained at greater risk than TMP-SMZ recipients (RR, 13.19; 95% CI, 3.54-49.12) and dapsone recipients (RR, 3.85; 95% CI, 1.12-13.31). Failure of C/P prophylaxis could be due, at least in part, to underdosing (clindamycin, 300 mg/d; primaquine, 15 mg/d). C/P recipients had more nonspecific diarrhea than did TMP-SMZ recipients (RR, 2.99; 95% CI, 1.61-5.55).     

Streptococcus group B and pregnancy: the therapeutic role of topical intravaginal clindamycin

OBJECTIVE: To evaluate the clinical and therapeutic efficacy of 2% clindamycin vaginal cream in pregnant women heavily colonized with group B streptococci (GBS). STUDY DESIGN: A prospective, clinical trial in which carriers of group B streptococci were randomized to receive topical intravaginal clindamycin or oral amoxicillin. PATIENTS: We randomized 105 pregnant women: 55 received 2% clindamycin vaginal cream (100 mg/day for 7 days) and 50 oral amoxicillin (2 g/day for 7 days). INTERVENTIONS: Patients were treated during pregnancy, none of them received intrapartum chemoprophylaxis. On the other hand, all the neonates, within 24 hours from delivery, were studied from the microbiological point of view, carrying out auricolar, nasal, oropharyngeal and umbilical cultures. RELIEFS: The eradication of the microorganism was evaluated by performing a vaginal culture after 6 weeks from the beginning of antibiotic therapy. RESULTS: The eradication rate of the microorganism was significantly higher in women treated with topical clindamycin compared with the group receiving oral amoxicillin (71% versus 36%; p < 0.05). The neonatal outcome was similar in the two groups in terms of gestational age at delivery and mean birthweight. None of the neonates was admitted to the neonatal intensive care unit and no cases of neonatal sepsis were recorded. CONCLUSIONS: From our experience we can conclude that, during pregnancy, a treatment with topical intravaginal clindamycin may be useful in the eradication of GBS.     

Evaluation of sequential thallium and gallium scans of the chest in AIDS patients

With decreasing incidence of pneumocystis carinii pneumonia (PCP) in AIDS as a result of prophylactic regimens, there is a higher incidence of tuberculosis (TB), mycobacterium avii complex (MAC), kaposi sarcoma and malignant lymphoma. There is a need for differentiating these various pathological entities. The purpose of this study was for a retrospective evaluation of sequential thallium and gallium scans in AIDS patients for differentiating intrathoracic kaposi sarcoma from malignant lymphoma and opportunistic infections. METHODS: A total of 181 patients had both studies completed between March 1992 and May 1994. The final diagnosis was verified only in 83 patients. Results were correlated with the CD4 counts, bronchoscopic and chest radiograph findings. RESULTS: In patients with pulmonary kaposi sarcoma and no opportunistic infections (19 patients), a thallium-positive, gallium-negative pattern was detected in 17 patients with a sensitivity of 89%. In the presence of kaposi sarcoma plus opportunistic infections, this pattern was only detected in 7 of 19 patients (sensitivity dropped to 37%). In 45 patients with opportunistic infections and no kaposi sarcoma, only two false-positive findings were found in patients with cytomegalic virus pneumonia for a specificity of 96%. For the whole group of 83 patients, sensitivity was 63%; specificity 95%; positive predictive value 92%; accuracy 81%; and negative predictive value 75%. CONCLUSION: A thallium-positive, gallium-negative pattern in AIDS patients has a high specificity for the diagnosis of kaposi sarcoma, however, the sensitivity dropped from 89% to 37% in the presence of opportunistic infections.     

Measurement of medullation in wool and mohair using an Optical Fibre Diameter Analyser

OBJECTIVE: Our purpose was to determine whether the continuation of antibiotics postoperatively after cesarean section in patients whose labors were complicated by chorioamnionitis would reduce the incidence of endometritis. STUDY DESIGN: Patients with a clinical diagnosis of chorioamnionitis treated with ampicillin during labor and who required cesarean delivery for obstetric indications received preoperative intravenous clindamycin and gentamicin and were randomized into 2 groups. Group 1 received no scheduled postoperative antibiotics and group 2 continued to receive clindamycin 900 mg every 8 hours and gentamicin 1.5 mg/kg every 8 hours until afebrile for a minimum of 24 hours (temperature 相似文献   

Dexamethasone therapy for bacterial meningitis in children: 2- versus 4-day regimen

Four-day dexamethasone therapy has been used to treat bacterial meningitis. This prospective, randomized study compared the effect of a 2-day versus a 4-day regimen. Children (n = 118, ages 2.5 months to 15 years) were evaluated; 50% of the cases were due to Neisseria meningitidis and 40% to Haemophilus influenzae type b. Patients were treated intravenously (iv) mainly with conventional antimicrobial therapy and were randomly assigned to receive dexamethasone, 0.15 mg/kg iv every 6 h for 2 or 4 days. The clinical response was similar for both dexamethasone regimens. The meningococcal meningitis patients survived without neurologic or audiologic sequelae. On long-term follow-up, neurologic sequelae or moderate or more severe unilateral or bilateral hearing impairment (or both) were found in 1.8% and 3.8% of patients treated with dexamethasone for 2 and 4 days, respectively. The 2-day regimen appears appropriate for the treatment of H. influenzae and meningococcal meningitis.     

Early transition to oral antibiotic therapy for community-acquired pneumonia: duration of therapy, clinical outcomes, and cost analysis

Our objective was to compare therapeutic outcome and analyse cost-benefit of a 'conventional' (7-day course of i.v. antibiotic therapy) vs. an abbreviated (2-day i.v. antibiotic course followed by 'switch' to oral antibiotics) therapy for in-patients with community-acquired pneumonia (CAP). We used a multicenter prospective, randomized, parallel group with a 28 day follow-up, at the University-based teaching hospitals: The Medical Center of Louisiana in New Orleans, LA and hospitals listed in the acknowledgement. Ninety-five patients were randomized to receive either a 'conventional' course of intravenous antibiotic therapy with cefamandole 1 g i.v. every 6 h for 7 days (n = 37), or an abbreviated course of intravenous therapy with cefamandole (1 g i.v. every 6 h for 2 days) followed by oral therapy with cefaclor (500 mg every 8 h for 5 days). No difference was found in the clinical courses, cure rates, survival or the resolution of the chest radiograph abnormalities among the two groups. The mean duration of therapy (6.88 days for the conventional group compared to 7-30 days for the early oral therapy group) and the frequencies of overall symptomatic improvement (97% vs. 95%, respectively) were similar in both groups. Patients who received early oral therapy had shorter hospital stays (7.3 vs. 9.71 days, P = 0.01), and a lower total cost of care ($2953 vs. $5002, P < 0.05). It was concluded that early transition to an oral antibiotic after an abbreviated course of intravenous therapy in CAP is substantially less expensive and has comparable efficacy to conventional intravenous therapy. Altering physicians' customary management of hospitalized patients with CAP can reduce costs with no appreciable additional risk of adverse patient outcome.     

Caring for AIDS patients at home--requirements for development of the concept

Exercise tolerance in chronic obstructive pulmonary disease (COPD) patients treated with oral aminophylline may be different from those treated with high-dose inhaled ipratropium bromide. The purpose of this study was to compare the effects of therapeutic doses of oral aminophylline with high-dose ipratropium bromide on spirometry and exercise tolerance. The study was conducted on three consecutive days in a double-blind, randomized, crossover fashion. Baseline studies obtained on each study day included vital signs, simple spirometry and a symptom-limited maximal cardiopulmonary stress test, after which patients received one of the following treatments on each day: Treatment 1, inhaled ipratropium (total dose of 144 micrograms) with placebo tablets; Treatment 2, inhaled placebo with oral aminophylline (400 mg); Treatment 3, inhaled placebo and placebo tablets. Simple spirometry was repeated at 60 and 120 min after baseline. Vital signs and cardiopulmonary stress testing was repeated at 120 min. Eighteen patients were enrolled in the study, and 17 of these completed the study. There was a significant (P < 0.05) increase in both forced expiratory volume in 1 s (FEV1), from 0.75 (0.21) to 0.92 (0.3), and forced vital capacity (FVC), from 1.8 (0.79) to 2.11 (0.84), with high-dose ipratropium despite prior beta-agonist therapy. Lack of improvement in exercise capacity was noted with ipratropium despite improvement in spirometry. These results suggest that elderly patients with severe COPD may have exercise limitation that is not directly dependent on severity of airflow obstruction. Ipratropium bromide and aminophylline demonstrated no acute effects on exercise capacity.     

Neutrophils from AIDS patients treated with granulocyte colony-stimulating factor demonstrate enhanced killing of Mycobacterium avium

Neutrophils isolated from AIDS patients have demonstrated improved growth inhibition of Mycobacterium avium when incubated with exogenous granulocyte colony-stimulating factor (G-CSF). In this clinical study, 30 AIDS patients without M. avium infection were randomized to receive 5 days of treatment with rifabutin, G-CSF, or both agents. The M. avium killing capacity of neutrophils harvested from each patient before intervention, during (day 4), and after therapy (day 7) was assessed. The mean change in human immunodeficiency virus load in the group receiving G-CSF alone was -0.07 log of viral RNA. There was a 90% reduction in M. avium growth after therapy for patients treated with G-CSF alone (P=.01), 59% for patients treated with both agents (P=.06), and 11% for patients treated with rifabutin alone (P=.84). Thus, neutrophils isolated from AIDS patients treated with G-CSF demonstrated a significant enhancement of killing of M. avium; there was no notable effect on virus load.     

Vasovagal syncope and increased baroreceptor activity: evidence for increased sensibility of the baroreflex and its rapid reversal with acute administration of metoprolol

In 17 patients suffering from recurrent episodes of vasovagal syncope as well as in 21 healthy subjects without clinical episodes of presyncope or syncope, we evaluated the reflex decrease in heart rate evoked by the phenilephrine test. In the syncopal patients, the measurements were taken 4-12 hours after the clinical appearance of syncope. We divided the syncopal patients as follows: 9 patients, undergoing pharmacological treatment, and 8 untreated patients (drug free arm). In the pharmacological arm of the study, an alternate, randomized administration of metoprolol (150 mg twice daily for 2 days) and verapamil (80 mg every 6 hours for 2 days) was provided. Therefore, in the pharmacological arm as well as in drug free patients, we tested again the baroreflex sensitivity, by means of iv phenilephrine bolus, 3 and 7 days after the clinical appearance of the syncopal event. The baroreflex sensitivity values were significantly higher in the syncopal group compared to the control group (21 +/- 5 vs 13 +/- 4.5 ms/mm Hg; p < 0.01). Of the two tested drugs, only the metoprolol produced a fast (day 3) decrease in baroreflex sensitivity. On the basis of measurements taken after 7 days, we noted a pattern of widespread reduction in baroreflex sensitivity values, found in both treated and untreated patients. In conclusion, patients with vasovagal syncope exhibited a more pronounced maximal parasympathetic activation compared to the control group. The high baroreflex sensitivity values were soon (day 3) reduced by metoprolol, but not by verapamil therapy; a spontaneous normalization in baroreflex sensitivity values was found 7 days after the clinical episode, regardless of therapy.     

Utility of low mA 1.5 pitch helical versus conventional high mA abdominal CT

We treated nine patients of mycoplasmal pneumonia with sparfloxacin (SPFX) the clinical efficacy, safety and usefulness of SPFX were evaluated. SPFX was administered orally at doses of 200 or 300 mg once daily, and we performed bronchoalveolar lavage (BAL) examinations in five patients. BAL was performed 5 hours after oral administration of 100 mg in one case, 19 hours after oral administration of 200 mg in four cases. Concentrations of SPFX and alubumine were measured in serum and in BALF (bronchoalveolar lavage fluid). The following results were obtained. 1. Nine patients were evaluated; eight patients judged as Good, one patient as Excellent. 2. The serum and BALF levels of SPFX was 0.79 microgram/ml, 0.107 microgram/ml 5 hours after single oral administration of 100 mg in one case and 19 hours after oral administration of 200 mg in four cases, those of levels of SPFX were 0.835 +/- 0.274 microgram/ml and 0.081 +/- 0.033 microgram/ml, respectively. 3. The ratio of SPFX/albumin in BALF was significantly higher than in the serum. From these results, we consider that SPFX is a useful antimicrobial agent for mycoplasmal pneumonia.     

Pharmacokinetics of hyperimmune anti-human immunodeficiency virus immunoglobulin in persons with AIDS

Hyperimmune anti-human immunodeficiency virus immunoglobulin (HIVIG) is an intravenous immunoglobulin prepared from HIV-infected asymptomatic donors with a CD4 cell count greater than 400 cells/microl and a high titer of antibody to HIV-1 p24 protein. Twelve persons with AIDS received four doses of HMG (two at 50 mg/kg of body weight and then two at 200 mg/kg) every 28 days. Pharmacokinetics were evaluated by measurement of anti-p24 antibody. HIVIG was well tolerated, and all participants completed the study. Three subjects who were not receiving Pneumocystis carinii pneumonia (PCP) prophylaxis developed PCP. The mean value for HIVIG clearance was 3.02 ml/kg/day at 50 mg/kg and 3.65 ml/kg/day at 200 mg/kg (P = 0.027); the mean trough antibody titers (reciprocal units) were 1,442 and 4,428, respectively. This study indicates that high titers of anti-p24 antibody can be maintained with a monthly administration schedule of HIVIG and that short-term safety is acceptable. Comparisons to evaluate the therapeutic potential of HIVIG are justified.