Randomized phase II trial of atovaquone with pyrimethamine or sulfadiazine for treatment of toxoplasmic encephalitis in patients with acquired immunodeficiency syndrome: ACTG 237/ANRS 039 Study. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039.

In this international, noncomparative, randomized phase II trial, we evaluated the effectiveness and tolerance of atovaquone suspension (1500 mg orally twice daily) plus either pyrimethamine (75 mg per day after a 200-mg loading dose) or sulfadiazine (1500 mg 4 times daily) as treatment for acute disease (for 6 weeks) and as maintenance therapy (for 42 weeks) for toxoplasmic encephalitis (TE) in patients infected with human immunodeficiency virus. Twenty-one (75%) of 28 patients receiving pyrimethamine (95% lower confidence interval [CI], 58%) and 9 (82%) of 11 patients receiving sulfadiazine (95% lower CI, 53%) responded to treatment for acute disease. Of 20 patients in the maintenance phase, only 1 experienced relapse.

Baseline human immunodeficiency virus type 1 phenotype, genotype, and RNA response after switching from long-term hard-capsule saquinavir to indinavir or soft-gel-capsule saquinavir in AIDS clinical trials group protocol 333.

AIDS Clinical Trials Group protocol 333 was an open-label trial of a switch from saquinavir (SQV) hard capsules (SQVhc) to indinavir (IDV) or saquinavir soft-gel capsules (SQVsgc) after >48 weeks of prior treatment with SQVhc. Eighty-nine subjects received IDV or SQVsgc or continued to receive SQVhc and continued unchanged treatment with non-protease-inhibitor antivirals for 8 weeks. Subjects receiving SQVhc then switched treatment to IDV.

Phase I studies of hypericin, the active compound in St. John's Wort, as an antiretroviral agent in HIV-infected adults. AIDS Clinical Trials Group Protocols 150 and 258.

Background: Hypericin, the active compound in St. John's Wort, has antiretroviral activity in vitro. Many HIV-infected persons use St.

Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group.

Background: In patients with human immunodeficiency virus (HIV) infection, combined treatment with several agents may increase the effectiveness of antiviral therapy. We studied the safety and efficacy of saquinavir, an HIV-protease inhibitor, given with one or two nucleoside antiretroviral agents, as compared with the safety and efficacy of a combination of two nucleosides alone.

Methods: In this double-blind trial, patients with HIV infection were randomly assigned to receive either saquinavir (1800 mg per day) plus both zidovudine (600 mg per day) and zalcitabine (2.

A controlled trial of fluconazole or amphotericin B to prevent relapse of cryptococcal meningitis in patients with the acquired immunodeficiency syndrome. The NIAID AIDS Clinical Trials Group and Mycoses Study Group.

Background: After primary treatment for cryptococcal meningitis, patients with the acquired immunodeficiency syndrome (AIDS) require some form of continued suppressive therapy to prevent relapse.

Methods: We conducted a multicenter, randomized trial that compared fluconazole (200 mg per day given orally) with amphotericin B (1 mg per kilogram of body weight per week given intravenously) in patients with AIDS who had completed primary therapy for cryptococcal meningitis with amphotericin B (greater than or equal to 15 mg per kilogram). To be eligible, patients had to have at least two negative cultures of cerebrospinal fluid immediately before randomization.

Concomitant high-level vancomycin and penicillin resistance in clinical isolates of enterococci.

Enterococci are important nosocomial pathogens among which resistance to multiple antibiotics is being recognized with increasing frequency. We characterized three clinical isolates from three New York City hospitals that demonstrated concomitant resistance to vancomycin (one VanA, two VanB phenotypes) and high-level resistance to penicillin. Two Enterococcus faecium strains were intrinsically highly resistant to penicillin and showed very low affinity for penicillin of penicillin-binding protein 5.

Production and preliminary characterization of monoclonal antibodies directed at two surface proteins of rhesus rotavirus.

A series of monoclonal antibodies was isolated which reacted with one of two major surface proteins of rhesus rotavirus. Thirty-six monoclonal antibodies immunoprecipitated the 82-kilodalton outer capsid protein, the product of the fourth gene, the viral hemagglutinin. These monoclonal antibodies exhibited hemagglutination inhibition activity and neutralized rhesus rotavirus to moderate or high titer.

IgM antibody responses to hepatitis B surface antigen in recipients of hepatitis B virus vaccine.

Both total anti-HBs and specific IgM anti-HBs were assayed in sequential serum specimens from five healthy volunteers receiving a primary immunization with the HBV vaccine. Four of the five subjects developed anti-HBs in the six-week period following primary immunization. Anti-HBs was first detectable between days 4 and 21 after initiation of vaccination.

Serological analysis of the subgroup protein of rotavirus, using monoclonal antibodies.

Ten monoclones directed to the 42,000-dalton inner structural protein of rotavirus were analyzed. Eight monoclones reacted broadly with antigenic domains common to virtually all mammalian rotaviruses. Two monoclones had specificities similar or identical to previously characterized subgroup specificities.

Proteins of Norwalk virus.

The proteins of the Norwalk virus were studied by polyacrylamide gel electrophoresis. Highly purified specifically immunoprecipitated virions appeared to contain a single primary structural protein with a molecular weight of 59,000. In addition, a soluble Norwalk viral protein with a molecular weight of 30,000 was identified in fecal specimens containing Norwalk virus.

Type B hepatitis: a review of current prospects for a safe and effective vaccine.

Several subunit vaccines against hepatitis B virus (HBV) have been developed and either are being evaluated or soon will be evaluated for their ability to prevent HBV infection in humans. Most of these preparations consist of highly purified, 22-nm spherical particles of hepatitis B surface antigen (HBsAg) that have been extracted from the plasma of chronic carriers of HBV and inactivated with formalin. Extensive testing in humans and chimpanzees showed these vaccines to be free of residual HBV or other harmful agents and to be capable of stimulating the production of protective antibodies to HBsAg in the majority of recipients.

Third component, HBeAg/3, of hepatitis B e antigen system, identified by three different double-diffusion techniques.

A third component, HB(e)AG/3, of the hepatitis B e antigen system has been detected, and it was consistently detected in three variations of the double-diffusion technique.

Type B hepatitis after needle-stick exposure: prevention with hepatitis B immune globulin. Final report of the Veterans Administration Cooperative Study.

Hepatitis B immune globulin (HBIG) and immune serum globulin (ISG) were examined in a randomized, double-blind trial to assess their relative efficacies in preventing type B hepatitis after needle-stick exposure to hepatitis B surface antigen (HBsAG)-positive donors. Clinical hepatitis developed in 1.4% of HBIG and in 5.

Antigens of hepatitis B virus: failure to detect HBeAg on the surfaces of HBsAg forms.

The particulate forms of HBsAg were analysed for the presence of HBeAG on their surfaces. By immunodiffusion analysis, anti-HBe did not form precipitin bands with the purified forms of HBSAg and hyperimmune guinea pig antisera to these forms did not react with HBeAg. Lines of non-identity were observed between the HBeAg determinants (e1 and e2) and the Dane particles and filaments isolated from an HBeAg-positive serum.

Transmission of hepatitis B to chimpanzees by hepatitis B surface antigen-positive saliva and semen.

To assess the infectivity of hepatitis B surface antigen (HBsAg)-containing body fluids other than blood, chimpanzees were inoculated intravenously with saliva and semen obtained from HBsAg-positive individuals implicated in non-percutaneous transmission of hepatitis B. Saliva and semen samples were negative for occult blood. The titer of HBsAg in saliva was on the average only 1/3,000 that of the corresponding serum.

Type B hepatitis: the infectivity of blood positive for e antigen and DNA polymerase after accidental needlestick exposure.

To determine the relation between the presence of donor DNA polymerase and e antigen, and recipient hepatitis, we tested, under code, serums from a controlled trial of hepatitis B immune globulin used to treat individuals accidentally inoculated with HBs Ag-positive blood. All recipients lacked antibody to HBs Ag. In 29 of 31 donors, both polymerase and e were in perfect agreement; both demonstrated a highly significant correlation with recipient hepatitis (P less than 0.

Modification of chronic hepatitis-B virus infection in chimpanzees by administration of an interferon inducer.

Chimpanzees chronically infected with hepatitis-B virus showed transient changes in several markers of infection when treated with the interferon inducer polyriboinosinic-polyribocytidylic acid-poly-l-lysine carboxymethyl cellulose. Serum Dane-particle-associated D.N.