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To investigate the effects of short-course regimen of oral ZDV for prophylaxis of HIV-1 subtype E vertical transmission among 'break-through' HIV-1 infected infants.
The purpose of these studies was to improve our understanding of nucleoside analog, antiviral, drug-induced anemia in HIV infection.
Informative drop-out arises in longitudinal studies when the subject's follow-up time depends on the unobserved values of the response variable. We specify a semiparametric linear regression model for the repeatedly measured response variable and an accelerated failure time model for the time to informative drop-out. The error terms from the two models are assumed to have a common, but completely arbitrary joint distribution. Using a rank-based estimator for the accelerated failure time model and an artificial censoring device, we construct an asymptotically unbiased estimating function for the linear regression model. The resultant estimator is shown to be consistent and asymptotically normal. A resampling scheme is developed to estimate the limiting covariance matrix. Extensive simulation studies demonstrate that the proposed methods are suitable for practical use. Illustrations with data taken from two AIDS clinical trials are provided.
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We compared oxidant-induced intracellular adenine nucleotide catabolism and cell membrane injury in 4 different human cell types. Responses to oxidant exposure were correlated with endogenous antioxidant enzyme activities in these cells. Blood monocytes, amniotic fibroblasts, umbilical vein endothelial cells in primary culture, and transformed bronchial epithelial cells (BEAS 2B) were exposed to 0.1-5 mM hydrogen peroxide (H2O2) for 4 h. Some experiments were conducted in cells pretreated with 3-amino 1:2,4-triazole (ATZ) to inactivate catalase or with 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) to inactivate glutathione (GSH) reductase. Depletion of adenine nucleotides and accumulation of their catabolic products (hypoxanthine, xanthine and uric acid) occurred to varying extent, monocytes being the most resistant. There was a mutual relationship between catalase and GSH reductase activities and maintenance of cellular adenine nucleotide levels during H2O2 exposure. GSH reductase inhibition rendered BEAS 2B cells susceptible to lytic injury by H2O2, assessed by release of lactate dehydrogenase and intact nucleotides into the medium, there was no correlation between these markers of such injury and endogenous antioxidant enzymes. We conclude that adenine nucleotide depletion and nucleotide catabolite accumulation relate closely with the antioxidant enzyme activities, whereas the lack of a similar correlation between the enzyme levels and markers of lytic cell injury suggest that intracellular antioxidant enzymes do not protect cells from membrane damage due to extracellular oxidants.
Because recent evidence indicates that human immunodeficiency virus type 1 (HIV-1) propagates in resting T lymphocytes in vivo, we wanted to evaluate the antiviral effects exerted by currently used nucleoside (NRTI) and non-nucleoside analog reverse transcription inhibitors in resting lymphocytes, and compare those effects to the ones obtained in activated lymphocytes.
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Patients with human immunodeficiency virus (HIV) infection are prone to the development of focal segmental glomerulosclerosis, a lesion in which increased mesangial cell proliferation and matrix synthesis may play a role. We undertook the present study to determine whether HIV sera may affect mesangial cell proliferation and matrix synthesis either directly or indirectly via effects on macrophage supernatants. Pooled HIV sera was found to significantly enhance (P < 0.01) mesangial cell proliferation in a concentration-related manner. Mesangial cell proliferation was significantly suppressed by two medications commonly utilized in HIV-infected patients, azidothymidine and trimethoprim/sulfamethoxazole, and was not significantly altered by lipopolysaccharide, suggesting that these medications as well as recurrent infection are unlikely to account for the proliferative effect of HIV sera. Supernatants from HIV sera-treated macrophages were found to significantly enhance (P < 0.01) mesangial cell incorporation of [3H]proline, a marker for synthesis of the matrix component collagen, compared to supernatants from control sera-treated macrophages. These results suggest that HIV sera may directly enhance mesangial cell proliferation and may indirectly increase mesangial cell matrix synthesis by altering macrophage secretory products. These effects may play a role in the development of glomerulosclerosis in patients with HIV infection.
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Retrospective study on 148 cART and 145 Zidovudine (ZDV) monotherapy-exposed infants identified from four Canadian centres where cART for PEP has routinely been prescribed in high-risk situations. Physician-reported adverse events and clinical outcomes were extracted by chart review. Haematological and growth parameters at birth, one and six months of age were compared between cART and ZDV-exposed infants using multivariate mixed effects modelling.
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The potency and selectivity index of the AZT-phenyl phosphate derivatives in thymidine kinase (TK)-deficient T cells were substantially enhanced by introducing a single para-bromo substitutent in the phenyl moiety. AZT-5'-(p-bromophenyl methoxyalaninyl phosphate) was 43-fold more potent than AZT-5'-(phenyl methoxyalaninyl phosphate) and was fivefold more potent than AZT in inhibiting human immunodeficiency virus (HIV) replication in TK-deficient CEM cells.
Metabolic and body composition variables were measured prospectively over 64 weeks in 334 antiretroviral-naive, HIV-infected subjects who were randomized to receive nelfinavir, efavirenz, or both, combined with zidovudine/lamivudine or didanosine/stavudine in a factorial design, multicenter trial. Subjects assigned to efavirenz (n = 110) were compared with those assigned to nelfinavir (n = 99); subjects assigned to zidovudine/lamivudine (n = 154) were compared with those assigned to didanosine/stavudine (n = 180). A subset of 157 subjects had serial dual-energy X-ray absorptiometry (DEXA) scans.
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A prospective open-label trial of zidovudine, lamivudine and ritonavir in treatment-naive asymptomatic HIV-infected individuals with CD4 cells > or = 400 x 10(6)/l.
The apparent permeability (Papp) results for the A-B direction were: Papp FLU A-B=0.54×10(-4)cm·s(-1), Papp METO A-B=7.99×10(-4)cm·s(-1), Papp 3TC A-B=4.58×10(-4)cm·s(-1) and Papp AZT A-B=5.34×10(-4)cm·s(-1). For the B-A direction, the Papp results were: Papp FLU B-A=0.56×10(-4)cm·s(-1), Papp METO B-A=0.25×10(-4)cm·s(-1), Papp 3TC B-A=0.24×10(-4)cm·s(-1) and Papp AZT B-A=0.19×10(-4)cm·s(-1).
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A short course of ZDVm in carefully selected women does not lead to the emergence of drug resistance based on either standard genotyping or cloning for the detection of minority species. Therefore, this strategy can still be considered in women wishing to prevent MTCT while minimizing antiretroviral exposure, without fear of compromising their future HIV care.
Of the 1291 patients started on therapy, 1253 completed a minimum of 3 months of follow-up. Rash and hepatitis were documented in 6.6% (95% confidence interval [CI]: 5.5-8.3) and 3.2% (95% CI: 2.3-4.8) of patients initiating therapy, respectively. There was significant improvement in CD4 counts over 2 years. Fourty-eight patients died, and 186 clinical events were documented in these patients. Tuberculosis was the most common cause of morbidity and mortality. Self-reported adherence was high.
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To assess the efficacy of d4T compared to AZT in combination with one NRTI and one non-nucleoside reverse transcriptase inhibitor (NNRTI), two additional NNRTIs, or one NRTI and one protease inhibitor (PI), as part of first-line ART for HIV-infected people in low-resource settings.
The objective of this study was to evaluate the long-term stability of the antiretroviral spermicide WHI-07 (5-bromo-6-methoxy-5,6-dihydro-3'-azidothymidine-5'-(p-bromophenyl)-methoxyalaninyl phosphate) in a polymer-based microemulsion. The recovery and stability of WHI-07 in gel-microemulsion was examined by a validated high-performance liquid chromatography (HPLC) method. The stability was examined over a period of 24 weeks at 3 controlled temperatures (4 degrees C, 25 degrees C, and 40 degrees C). The recovery of the prodrug from 0.5% to 2.0% WHI-07-loaded gel-microemulsion was 99.8%. HPLC analysis revealed that a 2% WHI-07-loaded gel-microemulsion stored at room temperature and cold temperatures for 24 weeks retained >90% of the prodrug, whereas those stored at 40 degrees C maintained 90% of initial WHI-07 for at least 10 weeks. The observed stability of WHI-07 in gel-microemulsion is of great importance for its widespread utility in various climatological conditions.
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Patients with (n = 93) or at risk for (n = 92) HIV-associated neurocognitive disorders underwent neuropsychological (NP) test batteries before HAART initiation and at follow-up. Changes in normatively adjusted summary NP test z scores were calculated for each subject. Two neuropenetration scores were calculated: the central nervous system penetration reference score (number of drugs in the combination among zidovudine, abacavir, stavudine, lamivudine, efavirenz, nevirapine, indinavir, and lopinavir-ritonavir) and the CNS penetration-effectiveness (CPE) score: a summary score of 1 (high: penetration: [corrected] zidovudine, abacavir, delavirdine, [corrected] nevirapine, amprenavir-ritonavir, fosamprenavir-ritonavir, [corrected] indinavir-ritonavir, and lopinavir-ritonavir), 0.5 (intermediate penetration: [corrected] stavudine, lamivudine, emtricitabine, efavirenz, amprenavir, fosamprenavir, [corrected] atazanavir-ritonavir, atazanavir, [corrected] and indinavir), and 0 (low penetration: remaining ARVs) [corrected] for each drug in the combination. Main outcome measures were changes in global NPZ scores and in summary z scores on 5 domains.
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A follow-up study was conducted for the Post-Exposure Prophylaxis of Infants trial in Blantyre, Malawi (PEPI-Malawi). In PEPI-Malawi, breast-feeding infants of HIV-infected women were randomized at birth to receive a either control regimen (single-dose nevirapine plus 1 week of zidovudine); the control regimen plus nevirapine to age 14 weeks; or the control regimen plus nevirapine and zidovudine to age 14 weeks. Infant HIV infection, maternal CD4 cell count, and HAART use were determined. Maternal HAART use was categorized as HAART eligible but untreated (CD4 cell count of <250 cells/microL, no HAART received), HAART eligible and treated (CD4 cell count of <250 cells/microL, HAART received), and HAART ineligible (CD4 cell count of 250 cells/microL). The incidence of HIV infection and the association between postnatal HIV transmission and maternal HAART were calculated among infants who were HIV negative at 14 weeks.
To investigate the bactericidal activity of antiviral and anticancer nucleoside analogues against a variety of pathogenic bacteria and characterize the activating enzymes, deoxyribonucleoside kinases (dNKs).
Thiazolo-iso-indolinone derivatives with high specificity toward the reverse transcriptase (RT) of human immunodeficiency virus type 1 (HIV-1) were identified. The most potent compound, BM +51.0836, inhibited HIV-1 RT at a 50% inhibitory concentration of 90 nM in vitro. In cell culture assays, similar 50% inhibitory concentrations were obtained with high specificity for HIV-1. These substances were equally active against a zidovudine-resistant isolate. No antiviral effect was observed with an HIV-2 isolate. HIV-1 isolates resistant to the thiazolo-iso-indolinones were generated in cell culture, and the nucleotide sequences of the respective RT genes were analyzed subsequently. Comparison of the deduced amino acid sequences with the wild-type sequence showed an amino acid change at position 181 (Tyr to Cys). Substitutions of amino acid Lys-101 and Lys-103 as well as Tyr-181 and/or Tyr-188 by site-directed mutagenesis led to resistance against the thiazolo-iso-indolinones. A chimeric HIV-2 RT, substituted with amino acids at positions 179 to 190 from HIV-1, acquired only partial susceptibility to BM +51.0836.
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This article discusses some of the limitations of observational data for assessing therapeutic effects and categorizes observational studies according to the strength of evidence. Ecologic studies based on AIDS surveillance registries have demonstrated improvements over time in median survival following the onset of AIDS, especially for patients with an initial diagnosis of Pneumocystis carinii pneumonia. Some of this improvement may be the result of secular changes in the stage of disease at diagnosis or in the completeness of detection of deaths in these cohorts, however. Other ecologic studies of the use of AZT in various subgroups strongly suggest that treatment had a favorable impact on US AIDS incidence rates in gay men in the year beginning July 1987. This article is reprinted with minor changes from Chapter 24 of AIDS Clinical Trials.
After 96 weeks, the mean percent change from baseline in total BMD was -2.5% (LPV/r) and -2.3% (EFV) (P < 0.01 for within-group changes in either arm; P = 0.86 for between-group differences). No alteration in the rate of BMD change was observed upon simplification to LPV/r monotherapy. Although soluble tumor necrosis factor-alpha receptor II concentrations at baseline and 24 weeks were at least marginally associated with subsequent changes in BMD (P = 0.06 and P = 0.028, respectively), these associations were no longer significant after adjustment for CD4 T cell count. Subjects with lower baseline CD4 T cell count, non-black race, and higher baseline glucose demonstrated a higher risk for >5% decrease in BMD.
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To assess the effectiveness of a simplified therapy for very nonadherent patients who had previously failed with HAART.