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Prophylactic intravenous immunoglobulin in HIV-infected children with CD4+ counts of 0.20 x 10(9)/L or more. Effect on viral, opportunistic, and bacterial infections. The National Institute of Child Health and Human Development Intravenous Immunoglobulin To evaluate the efficacy of intravenous immunoglobulin (IVIG) for prevention of viral, opportunistic, and minor bacterial infections in children infected with humanimmunodeficiencyvirus (HIV).Randomized, double-blind, placebo-controlled (...) , outpatient clinical trial comparing subjects treated with 400 mg of IVIG per kilogram of body weight every 28 days with those given albumin placebo.Twenty-eight clinical centers in mainland United States and Puerto Rico.Three hundred seventy-six children infected with humanimmunodeficiencyvirus with clinical or immunologic evidence of HIV disease, 313 of whom had entry CD4+ counts of at least 0.20 x 10(9)/L (greater than or equal to 200/mm3).The incidence of laboratory-proven and clinically diagnosed
Efficacy of nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. To determine the efficacy of the nonoxynol 9 contraceptive sponge in preventing sexual acquisition of the humanimmunodeficiencyvirus (HIV).Prospective, randomized placebo-controlled trial.Research clinic for prostitutes in Nairobi, Kenya.One hundred thirty-eight HIV-seronegative women were enrolled, of whom 74 were assigned to nonoxynol 9 sponge use and 64 to placebo use (...) with an increased frequency of genital ulcers (relative risk [RR], 3.3; P less than .0001) and vulvitis (RR, 3.3; P less than .0001) and a reduced risk of gonococcal cervicitis (RR, 0.4; P less than .0001). Twenty-seven (45%) of 60 women in the nonoxynol 9 sponge group and 20 (36%) of 56 women in the placebo group developed HIV antibodies. The hazard ratio for the association between nonoxynol 9 sponge use and HIV seroconversion was 1.7 (95% confidence interval [CI], 0.9 to 3.0). Using multivariate analysis
Double blind dose-response study of zidovudine in AIDS and advanced HIV infection. Nordic Medical Research Councils' HIV Therapy Group. To compare the efficacy and side effects of 400 mg, 800 mg, and 1200 mg zidovudine daily in patients with AIDS or advanced HIV infection.Randomised, double blind, parallel group multicentre study.Hospital departments of infectious diseases and dermatology in Denmark, Sweden, Norway, Finland, and Iceland.474 patients: 126 (27%) with AIDS; 248 (52%) with HIV (...) related symptoms; 100 (21%) with low CD4+ cell counts.Zidovudine 400 mg (160 patients), 800 mg (158), or 1200 mg (156) daily. All patients received one capsule from each of three bottles four times daily.Survival; incidence of new HIV related events; CD4+ cell count; quality of life; incidence of haematological side effects.460 (97%) of the 474 patients had not received zidovudine previously. The median follow up period was 19 months, during which the death rates in the three treatment groups were 23
Results of a randomized trial of partner notification in cases of HIV infection in North Carolina. We sought to compare two methods of notifying sex partners of subjects infected with the humanimmunodeficiencyvirus (HIV) or persons who had shared needles with them (needle-sharing partners): "patient referral," in which the responsibility for notifying partners was left to the patient, and "provider referral," in which providers attempted to notify partners.Names of sex partners and needle (...) -sharing partners and information on how to locate them were obtained from consenting HIV-infected subjects identified in the HIV-testing programs at three public health departments in North Carolina. The subjects were randomly assigned to a patient-referral group (in which patients had the initial responsibility for notifying their partners) or a provider-referral group (in which the study counselor notified the partners). The success of attempts to notify partners was monitored by means of interviews
A controlled trial of early versus late treatment with zidovudine in symptomatic humanimmunodeficiencyvirus infection. Results of the Veterans Affairs Cooperative Study. Zidovudine is recommended for asymptomatic and early symptomatic humanimmunodeficiencyvirus (HIV) infection. The best time to initiate zidovudine treatment remains uncertain, however, and whether early treatment improves survival has not been established.We conducted a multicenter, randomized, double-blind trial (...) that compared early zidovudine therapy (beginning at 1500 mg per day) with late therapy in HIV-infected patients who were symptomatic and had CD4+ counts between 0.2 x 10(9) and 0.5 x 10(9) cells per liter (200 to 500 per cubic millimeter) at entry. Those assigned to late therapy initially received placebo and began zidovudine when their CD4+ counts fell below 0.2 x 10(9) per liter (200 per cubic millimeter) or when the acquired immunodeficiency syndrome (AIDS) developed.During a mean follow-up period
Computer-based interview for screening blood donors for risk of HIV transmission. To test the ability of a computer-based interview to detect factors related to the risk of the humanimmunodeficiencyvirus (HIV) among potential blood donors and to determine donor reactions to the use of the interview.A comparison of the rate of detection of HIV-related factors elicited by a computer interview with that obtained by standard American Red Cross procedures for assessment of donor suitability (...) Cross written questionnaires and face-to-face interviews were used for donor assessment.The interview took an average of 8 minutes to complete. From among 272 donors who provided complete data, the computer identified 12 donors who reported either behaviors associated with a risk of HIV acquisition or symptoms compatible with the acquired immunodeficiency syndrome; none of these donors had been so identified either by routine written questionnaires or by face-to-face interviews used to screen
A controlled trial comparing continued zidovudine with didanosine in humanimmunodeficiencyvirus infection. The NIAID AIDS Clinical Trials Group. Although zidovudine is effective in patients with humanimmunodeficiencyvirus (HIV) infection, its efficacy may decline with prolonged use. Didanosine is another inhibitor of HIV reverse transcriptase. We evaluated the effectiveness of changing anti-HIV treatment from zidovudine to didanosine.This multicenter, double-blind study involved 913 (...) patients who had tolerated zidovudine for at least 16 weeks. The patients had the acquired immunodeficiency syndrome (AIDS), AIDS-related complex with less than or equal to 300 CD4 cells per cubic milliliter, or asymptomatic HIV infection with less than or equal to 200 CD4 cells per cubic milliliter. They were randomly assigned to receive 600 mg per day of zidovudine, 750 mg per day of didanosine, or 500 mg per day of didanosine.There were significantly fewer new AIDS-defining events and deaths among
Trial of glucose versus fat emulsion in preparation of amphotericin for use in HIV infected patients with candidiasis. To compare the tolerance, efficacy, and pharmacokinetics of amphotericin deoxycholate (Fungizone) prepared in a parenteral fat emulsion (Intralipid 20%) or glucose in HIV patients with candidiasis.Non-blind randomised controlled trial.University hospital; tertiary clinical care.22 HIV positive patients with oral candidiasis.Amphotericin 1 mg/kg/day given on four consecutive
A controlled trial of aerosolized pentamidine or trimethoprim-sulfamethoxazole as primary prophylaxis against Pneumocystis carinii pneumonia in patients with humanimmunodeficiencyvirus infection. The Dutch AIDS Treatment Group. Primary prophylaxis against Pneumocystis carinii pneumonia (PCP) is recommended for patients with humanimmunodeficiencyvirus (HIV) infection if their CD4 cell counts are below 200 per cubic millimeter (0.2 x 10(9) per liter). Either aerosolized pentamidine (...) or trimethoprim-sulfamethoxazole (co-trimoxazole) is commonly prescribed for prophylaxis, but the relative efficacy and toxicity of these agents are unknown.We conducted a multicenter trial involving 215 HIV-infected patients with no history of PCP but with CD4 cell counts below 200 per cubic millimeter. The patients were randomly assigned to one of three regimens: aerosolized pentamidine once a month, 480 mg of trimethoprim-sulfamethoxazole once a day (80 mg of trimethoprim and 400 mg of sulfamethoxazole
Ditiocarb sodium (diethyldithiocarbamate) therapy in patients with symptomatic HIV infection and AIDS. A randomized, double-blind, placebo-controlled, multicenter study. We randomized 389 symptomatic patients with humanimmunodeficiencyvirus (HIV) infection to ditiocarb sodium (400 mg/m2 orally for 24 weeks) or a placebo. Patients were well balanced according to Centers for Disease Control (CDC) group, CD4+ cell number, and duration of disease prior to entry. Ten new acquired immunodeficiency (...) considering as new opportunistic infections three events, which were clinically active at entry, but for which the definitive diagnosis was made during study (RR, 0.49). The administration of ditiocarb did not induce any major adverse clinical or biological reactions. We conclude that, in this study, ditiocarb was safe and reduced the incidence of opportunistic infections in patients with symptomatic HIV infection.
Safety of and immunological response to a recombinant vaccinia virus vaccine expressing HIV envelope glycoprotein. In a randomised phase I trial of a recombinant vaccina virus vaccine expressing the gp160 envelope gene of the humanimmunodeficiencyvirus (HIVAC-1e) 35 healthy, HIV-seronegative males, 31 of whom had a history of smallpox immunisation and 4 of whom were vaccinia naive, were vaccinated and then boosted 8 weeks later with HIVAC-1e or standard NY strain vaccinia virus. The frequency (...) , duration, and titre of virus isolation from the vaccination site and occurrence of local side-effects were similar between the two groups of vaccinees. Vaccinia-naive (vac-n) subjects shed virus from the vaccination site for longer and at a higher titre than did vaccinia-primed (vac-p) individuals (19 vs 7 days and 10(7) vs 10(5) pfu/ml, respectively). In-vitro T-cell proliferative responses to one or more HIV antigen preparations developed in 13 of 16 vaccinia-primed subjects inoculated with HIVAC-1e
A phase I evaluation of the safety and immunogenicity of vaccination with recombinant gp160 in patients with early humanimmunodeficiencyvirus infection. Military Medical Consortium for Applied Retroviral Research. Despite multiple antiviral humoral and cellular immune responses, infection with the humanimmunodeficiencyvirus (HIV) results in a progressively debilitating disease. We hypothesized that a more effective immune response could be generated by post-infection vaccination with HIV (...) -specific antigens.We performed a phase I trial of the safety and immunogenicity of a vaccine prepared from molecularly cloned envelope protein, gp160, in 30 volunteer subjects with HIV infection in Walter Reed stage 1 or 2. The vaccine was administered either on days 0, 30, and 120 or on days 0, 30, 60, 120, 150, and 180. HIV-specific humoral and cellular immune responses were measured; local and systemic reactions to vaccination, including general measures of immune function, were monitored.In 19
Comparison of ribavirin and placebo in CDC group III humanimmunodeficiencyvirus infection. Spanish Ribavirin Trial Group. To assess the efficacy and safety of ribavirin in patients with humanimmunodeficiencyvirus (HIV) infection a multicentre, placebo-controlled, prospectively randomised trial was conducted in CDC group III HIV-infected individuals between February, 1988, and October, 1989. Mean treatment time was 39 weeks (range 6-52); 152 individuals were enrolled, of whom 133 could (...) be evaluated. The two treatment groups were similar at baseline and 66% of all subjects had intravenous drug abuse as the main risk factor for HIV infection. Ribavirin was given at a dose of 15 mg/kg daily by mouth (average daily dose 1000 mg). 9 of 67 patients in the placebo group (13.4%) progressed to CDC Groups IVA, C1, or D vs 6 of 66 (9%) in the ribavirin group. Progressions to group IVC2 were 7 (10.4%) and 9 (13.6%), respectively. These differences are not statistically significant. There were
Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic humanimmunodeficiencyvirus infection. The National Institute of Child Health and Human Developments Intravenous Immunoglobulin Study Group. Serious recurrent bacterial infections are a major cause of morbidity and mortality in children infected with the humanimmunodeficiencyvirus (HIV). Because intravenous immune globulin has been shown to prevent bacterial infection in patients with primary (...) immunodeficiency and in uncontrolled studies of HIV-infected children, we undertook a multicenter study of its safety and efficacy in children with symptomatic HIV infection.In a double-blind trial, 372 HIV-infected children (mean age, 40 months) with clinical or immunologic evidence of HIV disease were randomly assigned to receive either intravenous immune globulin (400 mg per kilogram of body weight) or placebo (0.1 percent albumin) every 28 days. The children were stratified into two groups according to CD4
--University-based referral centers. PARTICIPANTS--Two thousand forty-eight persons with asymptomatic or mildly symptomatic humanimmunodeficiencyvirus infection were analyzed. Of these, 155 were black, 190 were Hispanic, 144 were women, and 221 were intravenous drug users. All randomized subjects were included in the analysis. INTERVENTION--Participants in the AIDS Clinical Trials Group protocol 016 were assigned to receive a placebo or a 1200-mg daily dose of zidovudine. Participants in the AIDS (...) Effects of zidovudine therapy in minority and other subpopulations with early HIV infection. OBJECTIVE--The purpose of this study was to determine whether the beneficial effects of zidovudine seen overall in two recently completed placebo-controlled clinical trials are also apparent in blacks, Hispanics, women, and intravenous drug users. DESIGN--Two double-blind placebo-controlled randomized clinical trials, protocols 016 and 019, conducted by the AIDS Clinical Trials Group. SETTING
Antibody responses to Haemophilus influenzae type B vaccines in men with humanimmunodeficiencyvirus infection. Persons with humanimmunodeficiencyvirus (HIV) infection are at increased risk for serious infections caused by Haemophilus influenzae, yet there are few data on their antibody responses to the H. influenzae type b vaccines.We evaluated antibody responses in 248 men who were randomly assigned to receive a single dose of either the H. influenzae type b polysaccharide (PRP) vaccine (...) or the polysaccharide-mutant diphtheria toxoid conjugate vaccine (PRP-CRM). The subjects were stratified into four groups: seronegative men (67 subjects), men with asymptomatic HIV infection (79), men with symptomatic HIV infection (47), and men with the acquired immunodeficiency syndrome (AIDS) (55).Before immunization, the subjects with AIDS had the lowest PRP-antibody titers; 40 percent had titers below the putative protective level (less than 0.15 micrograms per milliliter). In the seronegative subjects, those
a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Fleurette F, Durieux, P. Capacity of HIV1 p24 antigen screening to reduce the current residual risk of contracting HIV infection following transfusion. Paris: L'Agence Nationale d'Accreditation d'Evaluation en Sante (ANAES) 1991: 20 Authors' objectives Given that a screening procedure to detect HumanImmunodeficiencyVirus (HIV) itself rather than the immune response, was made available (...) Capacity of HIV1 p24 antigen screening to reduce the current residual risk of contracting HIV infection following transfusion Capacity of HIV1 p24 antigen screening to reduce the current residual risk of contracting HIV infection following transfusion Capacity of HIV1 p24 antigen screening to reduce the current residual risk of contracting HIV infection following transfusion Fleurette F, Durieux, P Record Status This is a bibliographic record of a published health technology assessment from
Cost-effectiveness of low dose zidovudine therapy for asymptomatic patients with humanimmunodeficiencyvirus (HIV) infection Cost-effectiveness of low dose zidovudine therapy for asymptomatic patients with humanimmunodeficiencyvirus (HIV) infection Cost-effectiveness of low dose zidovudine therapy for asymptomatic patients with humanimmunodeficiencyvirus (HIV) infection Schulman K A, Lynn L A, Glick H A, Eisenberg J M Record Status This is a critical abstract of an economic evaluation (...) the value of this intervention. Bibliographic details Schulman K A, Lynn L A, Glick H A, Eisenberg J M. Cost-effectiveness of low dose zidovudine therapy for asymptomatic patients with humanimmunodeficiencyvirus (HIV) infection. Annals of Internal Medicine 1991; 114(9): 798-802 PubMedID Other publications of related interest Comment in: Annals of InternalMedicine 1991;115(8):655-6. Indexing Status Subject indexing assigned by NLM MeSH Acquired Immunodeficiency Syndrome /economics /prevention & CD4