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Two concentration-controlled trials (CCTs) defined the relationship between plasma concentrations of 3'-deoxy-3'-fluorothymidine (alovudine) and changes in surrogate markers of antiretroviral activity. In an initial open-label CCT involving 14 subjects infected with human immunodeficiency virus (HIV), unacceptable hematologic toxicity occurred when the area under the concentration-time curve during a 12-h dosing interval (AUC12) was > or = 300 ng*h/mL. Consequently, 46 subjects were assigned to AUC12s of 50, 100, or 200 ng*h/mL for up to 16 weeks in a prospective, randomized, double-blind CCT. Alovudine caused a concentration-dependent reduction in p24 antigen and peripheral blood mononuclear cell HIV titers within 4 weeks of start of treatment. The AUC12 producing a 50% reduction in p24 (108 ng*h/mL) had a trough concentration identical to the reported IC50 of alovudine in HIV-infected H9 cells. It may be possible to predict the antiretroviral activity of certain nucleoside analogues as a function of plasma drug concentration.

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We compared the efficacy and safety of two beta-lactam-beta-lactamase inhibitor combinations, namely, piperacillin-tazobactam and ticarcillin-clavulanate, in the treatment of complicated bacterial infections of skin that required hospitalization. The study was a randomized, double-blind, comparative trial involving 20 centers. The infections were classified as (i) cellulitis with drainage, (ii) cutaneous abscess, (iii) diabetic or ischemic foot infection, and (iv) infected wounds and ulcers with drainage. The clinical response rates were comparable for the two treatment regimens (61% of the patients were cured with piperacillin-tazobactam and ticarcillin-clavulanate and improvement was seen in 15 and 16% of patients treated with piperacillin-tazobactam and ticarcillin-clavulanate, respectively). Both regimens were found to be safe and well tolerated. These data support the use of piperacillin-tazobactam for initial empiric therapy of hospitalized patients with complicated skin and skin structure infections.

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OBJECTIVE: To compare the clinical efficacy and safety of trimethoprim-sulfamethoxazole (TMP-SMX) with pentamidine in the therapy of Pneumocystis carinii pneumonia (PCP) in patients with AIDS. PATIENTS, PARTICIPANTS: TMP-SMX (TMP, 20 mg/kg/day plus SMX, 100 mg/kg/day) was compared with pentamidine (4 mg/kg/day), both administered intravenously for 21 days in a prospective randomized treatment trial of 163 patients diagnosed with PCP between November 1984 and May 1988. RESULTS: Ninety-two evaluable patients received TMP-SMX as initial therapy; 68 received pentamidine. Failure to complete therapy was common. Of those receiving TMP-SMX, 39 (42%) required change in therapy because of failure to respond, and an additional 31 (34%) because of drug toxicity. This compared with 27 (40%; P = 0.733) and 17 (25%; P = 0.235), respectively, in the pentamidine-treated group. The overall survival rates were similar in the two groups, 62 out of 92 (67%) initially administered TMP-SMX versus 50 out of 68 (74%) initially administered pentamidine (P = 0.402). The survival rates for patients requiring a change in therapy because of failure to respond was 46% (18 out of 39) for the TMP-SMX group compared with 56% (15 out of 27) for the pentamidine group. When a change in therapy was made because of toxicity, survival rates were 97% (30 out of 31) for those receiving TMP-SMX versus 94% (16 out of 17) for those receiving pentamidine. CONCLUSION: TMP-SMX and pentamidine are of equivalent efficacy as initial therapies for PCP in patients with AIDS.

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The important role of chemoprophylaxis for the prevention of Pneumocystis carinii pneumonia (PCP) in human immunodeficiency virus type 1 (HIV)-infected patients is undisputed. The most cost-effective regimen, however, is unknown. We reviewed our experience at two hospitals in the New York City area in which low-dose, intermittent therapy with the combination of trimethoprim and sulfamethoxazole was used to prevent PCP in HIV-infected patients. During a total of 202 months of primary prophylaxis in 32 patients and 319 months of secondary prophylaxis in 35 patients, PCP was diagnosed only once. More than 80% of patients were receiving zidovudine concomitantly. Adverse reactions to trimethoprim-sulfamethoxazole occurred in 31% and 52% of those receiving primary or secondary prophylaxis, respectively. When those patients who were considered ineligible to receive trimethoprim-sulfamethoxazole prophylaxis (principally based on a prior adverse drug reaction) are also factored in, then approximately 50% of HIV-infected patients are candidates for long-term trimethoprim-sulfamethoxazole prophylaxis. The projected cost savings of this prophylaxis regimen, compared with those currently recommended by the US Public Health Service, are enormous.

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Pulmonary tuberculosis in AIDS/ARC patients is an increasing problem. To assess the utility of acid-fast smears of pulmonary secretions in this patient population, we evaluated 38 AIDS/ARC patients with culture-positive pulmonary infection. A control group consisted of 57 non-AIDS/ARC patients, who also did not belong to an AIDS risk group, diagnosed during the same period. The number of culture-positive sputum samples evaluated per patient was similar in both groups (3.82 +/- 3.11 AIDS/ARC vs 4.47 +/- 2.83 control group). Significantly fewer AIDS/ARC patients, 45 percent, however, had a positive acid-fast smear compared with the control group, 81 percent (p less than 0.001). The initial sputum smear submitted was positive in only 29 percent of the AIDS/ARC group compared with 61 percent of control subjects (p less than 0.01). Further, greater than or equal to 5 negative smears were found in 60 percent of the evaluable AIDS/ARC patients compared with just 13 percent of control subjects (p less than 0.01). More extensive findings on chest roentgenograms were not associated with a significantly higher yield of smear positivity in the AIDS/ARC group. We conclude that acid-fast smears on sputum specimens are a relatively insensitive test for pulmonary tuberculosis in AIDS/ARC patients.

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Generalized lymphadenopathy in intravenous drug abusers (IVDAs) at risk for AIDS has not been well studied. We have retrospectively analyzed the results of lymph node biopsies obtained from 27 patients referred to the Infectious Diseases Service for evaluation of generalized lymphadenopathy and suspected AIDS during a recent 18-month period. Fourteen of the patients were heterosexual IVDAs, 7 were male homosexual IVDAs, and 6 were male homosexual non-IVDAs. All of the patients were residents of the Bronx, New York. Mycobacterium tuberculosis (TB) was the most frequent diagnosis established on lymph node biopsies from IVDAs, in 12 out of 21 (57%). Tuberculous adenitis was not diagnosed in the 6 non-IVDAs. All TB patients were febrile, 11 (91%) had lost weight, and 10 (84%) had an abnormal chest roentgenogram. The 5TU PPD skin test, however, was reactive in only 2 (16%) of 12 patients. Tuberculosis is important to consider in patient populations with exposure histories to both AIDS and TB. The alarmingly high prevalence of TB in this drug addict population emphasizes the importance of lymph node biopsies with acid-fast smears and mycobacterial cultures in symptomatic IVDAs. Preventive antituberculosis therapy for HIV-positive persons, especially IVDAs, with a history of positive tuberculin reactions or of recent household contact should be seriously considered.

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The clinical findings in 13 drug abusers and one homosexual man with tuberculosis and the acquired immunodeficiency syndrome (AIDS) from New York City are described. Tuberculosis preceded the diagnosis of AIDS in nine of the 14 patients by a mean of 7 months and occurred within the same month in the remaining five. The presence of thrush, generalised lymphadenopathy, lymphopenia, cutaneous anergy and chest radiographs showing hilar adenopathy and/or lower lobe infiltrates was common among the patients in whom tuberculosis preceded AIDS. Eight of our patients had extra-pulmonary tuberculosis, six had disseminated tuberculosis and five had tuberculous lymphadenitis. Cultures of tissue biopsies may be positive for Mycobacterium tuberculosis despite the absence of acid fast bacilli or granulomas on microscopic examination. Tuberculosis generally responded to chemotherapy, but the majority of patients died from opportunist infections.

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Forty patients with acquired immunodeficiency syndrome (AIDS), 70% of whom were intravenous drug abusers (IVDAs), were seen over a 20-month period (July 1, 1981, through Feb 28, 1983). Most of the patients came from two inner-city sections of New York City and from nearby correctional facilities. Eighty-five percent of the patients were black or Hispanic; only 15% were white. Unique features of AIDS in this mostly heterosexual population were the high incidence of opportunistic infections (90% of the patients), the low incidence of Kaposi's sarcoma (10%), and the high mortality rate (34% died during initial hospitalization, 74% after one year of follow-up). Tuberculosis occurred in 10% of cases, preceding other opportunistic infections by four to 24 months. We found that AIDS was a common disease among inpatient IVDAs, and in one of the participating hospitals, its incidence was similar to that of infective endocarditis. Acquired immunodeficiency syndrome should be considered as the underlying illness in all IVDAs with oral thrush, shortness of breath, pneumonia, or extra-pulmonary tuberculosis.

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A case report of a healthy 33-year-old man with Mycoplasma pneumoniae pneumonia who concomitantly had the acquired Pelger-Huet anomaly develop is presented. Up to 31% of his total white blood cell count was comprised of Pelger-Huet cells at the height of his clinical illness. The Pelger-Huet cell count returned to 0% after doxycycline therapy and resolution of the pneumonia. No other explanation for the Pelger-Huet anomaly could be determined. A review of the pertinent hematologic literature is included.

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Infection with human T-cell lymphotropic virus III (HTLV-III) is closely linked to the acquired immunodeficiency syndrome (AIDS). We evaluated the risk of nosocomial infection with HTLV-III by testing for antibodies to HTLV-III among hospital employees, including victims of needle-stick exposure, endoscopists, pathologists, and laboratory workers. Assays for antibody against the virus were performed by enzyme-linked immunosorbent assay and electrophoretic (Western blot) techniques. Although all 22 of our patients with AIDS and 6 of 7 with AIDS-related complex were found to have antibodies to HTLV-III when both assays were employed, none of the 85 employees with nosocomial exposure to specimens from patients with AIDS were positive for HTLV-III antibody. These studies must be regarded as preliminary, but they suggest that when current hospital isolation procedures are employed, the risk of nosocomial transmission of HTLV-III is low.

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During a two-year period, two drug addicts and one homosexual patient with acquired immunodeficiency syndrome (AIDS) developed persistent Salmonella typhimurium or S. enteritidis bacteremia early in the course of their syndrome. A fourth patient, also a male homosexual with recurrent S. typhimurium bacteremia and urinary tract infection, is being closely followed prospectively for the development of AIDS. Nontyphoidal salmonella bacteremia appears to be an emerging problem in AIDS patients and may be the earliest manifestation of a cell-mediated defect.

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In two separate experiments, six months apart, utilizing different controls and different methods, sodium salicylate in anti-inflammatory doses was administered by gavage to mice with acute Chagasic myocarditis (T. cruz) at the onset of parasitemia. Sodium citrate was used as a control. Animals given salicylate showed decreased blood trypanosome counts and myocardial pseudocyst formation, both absolutely and in the rates of formation. Decreased inflammation and necrosis were associated with salicylate therapy. Survival of the animals was not increased by treatment. The effects cannot be explained by sodium ion concentration, the technique of gavage, or any factor except the presence of salicylate ion.

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