Each subject provided a series of semen samples that was examined for HIV-1 by virus culture, polymerase chain reaction (PCR) and transmission electron micrography.
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AZT, at concentrations 250 microM and above, caused depopulation of the Leu-19-positive myotubes, destructive changes in the mitochondria consisting of swelling, lamellar inclusions and multiple concentric cristae, accumulation of lipid droplets, and increase lysosomes. L-Carnitine increased the number of Leu-19-positive myotubes from 3.4 +/- 0.6 to 9.4 +/- 1.2, preserved the morphology of the mitochondria, increased their volumetric density from 2.5 +/- 0.4 to 6.0 +/- 0.7, and reduced the volumetric density of the lipid droplets from 12.2 +/- 4.9 to 1.4 +/- 0.7 and of the lysosomes from 15.6 +/- 3.6 to 3.9 +/- 1.4 (p < 0.001).
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In this study of HIV positive patients with PPROM, the mother-to-child transmission rate of HIV did not seem to be related to the duration of rupture of membranes prior to delivery.
To assess the association between human leukocyte antigen (HLA) haplotypes and the incidence rates of CD4 decline to < 20% and to AIDS.
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Antiretroviral therapy and prophylaxis during the antepartum, intrapartum and postpartum periods, cesarean delivery and avoidance of breast milk significantly reduce vertical transmission of HIV.
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The aim of this study was to develop and evaluate a Zidovudine (AZT)-loaded microparticulated bioadhesive vaginal gel (MBVG) in order to obtain a controlled releasing, safe gel delivery system. AZT microparticles (ZMPs) were evaluated for encapsulation efficiency, drug loading, surface morphology and in vitro drug release profiles and drug release mechanism and optimized. The optimized ZMPs were then encompassed in bioadhesive gel using different bioadhesive polymers and evaluated for the drug encapsulation efficiency, drug loading, in vitro and in vivo drug release profiles, drug release mechanism and vaginal irritancy study. From the dissolution data of ZMP4 and MBVG4 showed a zero-order diffusion pattern and Fickian diffusion case I transport mechanism in 24 and 36 h, respectively. On the basis of a pharmacokinetic study of MBVG4 (containing ZMP: Carbopol 1:4), it was found to have better bioavailability, larger AUC and T(max) in comparison to an oral pure suspension of AZT.
The Patient Medication Adherence Questionnaire Version 1.0 (PMAQ-V1.0) is a patient-reported adherence instrument to assess medication-taking behaviors and identify barriers to adherence with antiretroviral therapy. To assess the correlation between adherence and virologic outcome, the PMAQ-V1.0 was administered to 194 antiretroviral-experienced adults with HIV infection enrolled in a 16-week evaluation of protease inhibitor-containing regimens featuring a lamivudine/zidovudine combination tablet. At baseline, plasma HIV-1 RNA levels were less than 10,000 copies/mL and CD4(+)-cell counts were equal to or greater than 300 x 10(6)/L; patients had been receiving a conventional regimen of lamivudine + zidovudine (separately) plus a protease inhibitor for at least 10 weeks immediately prior to the study. Forty-eight percent of patients who reported missing at least one dose of a nucleoside reverse-transcriptase inhibitor (NRTI) during the study had detectable plasma HIV-1 RNA, compared with 26% of patients who reported no missed doses (P = .002). Patients who missed at least one dose of an NRTI or protease inhibitor were 2.5 times more likely to have quantifiable HIV-1 RNA than those who reported no missed doses. Patients who reported fewer barriers and more motivators to adherence had better virologic outcomes (P = .001). Several dimensions of the PMAQ-V1.0 did not function as well as hypothesized. In this study, self-reported adherence derived from the PMAQ-V1.0 predicted virologic outcomes, but further refinement of the dimensions appears warranted.
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A retrospective analysis was conducted of HIV/AIDS cases registered at the University Hospital in Kuala Lumpur, Malaysia. There were 104 such cases, but, due to incomplete data or lost to follow up, the analysis included only 66 HIV/AIDS cases. The age of the 66 HIV/AIDS cases ranged from 0 to 60 years. 89.4% were 21-40 years old. The female to male ratio was 1:10. 53.8% of the HIV/AIDS cases had acquired HIV via intravenous drug use. The next most common HIV transmission modes were heterosexual and homosexual intercourse (20% and 13.8%, respectively). There were 73 episodes of AIDS-defining illness among the 66 patients. The most common illnesses were Pneumocystis carinii pneumonia (PCP) (32.9%) and esophageal candidiasis (16.4%). Of the 28 patients who had at least 1 CD4+ measurement, 54% had a CD4+ count less than 500/mcl. 66% of them had at least 1 AIDS-defining illness. 17 HIV/AIDS patients had already died. The leading causes of death were fulminant pneumonia (23.5%) and PCP (17.6%). The probability of survival at 2.7 years after HIV diagnosis was 50%. The probability of survival free from AIDS-defining illness at 2 years was also 50%. Reasons for poor survival included delay in HIV diagnosis, presentation late in the course of HIV disease (the case in 50% of HIV/AIDS patients at the hospital), poor compliance to follow-up, and non-availability of zidovudine until recently.
Data of 1844 patients (1198-Male & 645-Female) enrolled from November 2005 to December 2007 was collected. 222 patients developed about 228 ADRs with prevalence of 12.36%. Peripheral neuropathy and anemia were highly prevalent ADRs. Nevirapine induced rash and SJ syndrome developed within first month of treatment followed by anemia, hepatitis and gastritis which developed within 6 months after initiation of ART. 96.49% ADRs were found to be possible and 3.50% probable by WHO probability scale. 20 (8.77%) were mild, 176 (77.19%) were moderate and 32 (14.02%) were severe in nature. 183 (80.26%) ADRs were found to be non-serious whereas 45 (19.74%) were serious. Only 2.63% ADRs were found to be preventable which included vomiting and rash. Odds ratio with 95% CI was calculated.
Although HIV-1 reverse transcriptase (RT) DNA polymerase and ribonuclease H (RNase H) activities reside in spatially distinct domains of the enzyme, inhibitors that bind in the RT polymerase domain can affect RNase H activity. We used both gel assays and a real-time FRET assay to analyze the impact of three mechanistically distinct RT polymerase inhibitors on RNase H activity in vitro. The nucleoside analogue 3'-azido-3'-deoxythymidine triphosphate (AZT-TP) had no effect, whereas the pyrophosphate analogue phosphonoformate (PFA) inhibited RNase H activity in a concentration-dependent manner. Nonnucleoside RT inhibitors (NNRTIs) enhanced RNase H catalysis, but the cleavage products differed substantially for RNA/DNA hybrid substrates of different lengths. A comparison of 61 different RT crystal structures revealed that NNRTI binding opened the angle between the polymerase and RNase H domains of the p66 subunit and reduced the relative motion of the thumb and RNase H regions, suggesting that NNRTI enhancement of RNase H cleavage may result from increased accessibility of the RNase H active site to the RNA/DNA hybrid duplex. We also examined the effects of combining a diketo acid (DKA) RNase H inhibitor with various RT polymerase inhibitors on polymerase-independent RNase H cleavage, RNA-dependent DNA polymerization, and in reverse-transcription assays. Interestingly, although the NNRTI decreased DKA potency in polymerase-independent RNase H assays, NNRTI/DKA combinations were synergistic in inhibiting reverse transcription overall, indicating that regimens incorporating both NNRTI and RNase H inhibitors may be therapeutically beneficial.
A selective and sensitive high performance liquid chromatography with UV detector (HPLC-UV) method was developed and validated from human plasma. Nevirapine and internal standard (IS) zidovudine were extracted from human plasma by liquid-liquid extraction process using methyl tert-butyl ether. The samples were analysed using Inertsil ODS 3, 250×4.6 mm, 5 μ column using a mobile phase consists of 50 mM sodium acetate buffer solution (pH-4.00±0.05): acetonitrile (73:27 v/v). The method was validated over a concentration range of 50.00 ng/ml to 3998.96 ng/ml. The method was successfully applied to bioequivalence study of 10 ml single dose nevirapine oral suspension 50 mg/5 ml in healthy male volunteers.
To study the effect of sequential or additive use of zalcitabine or didanosine on survival in 308 human immunodeficiency virus-infected patients with advanced disease treated with zidovudine, an observational study using time-dependent Cox proportional hazards models was done. Changing to sequential or additive therapy was based on deterioration of a patient's health status, a significant drop in CD4 cell count, or intolerance for zidovudine. The median CD4 cell count at baseline was 110 x 10(6)/L; 42% of patients had AIDS. The median count before a change in therapy was 50 x 10(6)/L. Additive or sequential treatment was associated with an increased risk for death (relative hazard, 1.59; 95% confidence interval [CI], 1.01-2.49; and 1.58; 95% CI, 1.10-2.37, respectively). Adjustment of the models for prognostic factors failed to substantially affect this observation. Possibly the lack of benefit in this study is because patients switched therapy at advanced stages, whereas the switch may be more effective in early disease.
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DNA repair is an essential outcome of DNA damage, which may compromise the end point of various in vitro and in vivo test systems of the genotoxicity evaluation. poly(ADP-ribose) polymerase (PARP) enzymes have an essential role in DNA repair. Here, we investigated the effect of 3-AB, a PARP inhibitor on the sensitivity of comet and PBMN assays.
ECS is an efficacious intervention for the prevention of MTCT among HIV-1-infected women not taking ARVs or taking only zidovudine. The risk of PPM with ECS is higher than that associated with vaginal delivery, yet lower than with NECS. Among HIV-1-infected women, more advanced maternal HIV-1 disease stage and concomitant medical conditions (e.g., diabetes) are independent risk factors for PPM. The risk of MTCT of HIV-1 according to mode of delivery among HIV-1-infected women with low viral loads (low either because the woman's HIV-1 disease is not advanced, or because her HIV-1 disease is well-controlled with ARVs) is unclear. Therefore, an important issue to be addressed in one or more large studies (individual studies or an individual patient data meta-analysis combining data from more than one study) is assessment of the effectiveness of ECS for prevention of MTCT of HIV-1 among HIV-1-infected women with undetectable viral loads (with or without receipt of highly active ARV therapy (HAART)).
Hearing loss was common, seen in 29 subjects (29%). It was significantly associated with age and history of ear infection and tended to be more common in subjects prescribed antiretroviral agents. An interaction existed between age and antiretroviral therapy; the association between hearing loss and antiretroviral therapy was significant for subjects aged 35 years or older, but not for subjects younger than 35 years. In subjects aged 35 years or older, this association remained significant using a multivariate model that included those variables found to have the greatest potential for confounding (odds ratio, 4.6; 95% confidence interval, 1.0-20.5; P = .05).
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Most patients were homosexual (71%), and 91% were male. Only one patient (3%) had a single exposure with a known HIV-infected person and was therefore eligible for PEP. Eight patients (23%) who did not know the HIV status of their partner would have been eligible considering single exposure as a sufficient criterion for PEP. Oro-genital contact appears to account for transmission in four instances. Eleven persons (31%) were infected after sexual contact with their stable partner, of whom 7 did not known his/her HIV status. Twelve patients (34%) were infected after multiple unprotected sexual contact with unknown partners.
Since 1986, the French Perinatal Cohort prospectively enrolled all HIV-infected women in 90 centers and collected follow-up on their children through 2 years of age. All CHDs were reviewed by a specialist blinded to exposures. Additionally, in a randomized trial (PRIMEVA ANRS 135) of 2 ARV regimens during pregnancy, 1 of which was without nucleoside reverse transcriptase inhibitors, infants had a specific follow-up including echocardiography at 1 month and 12 months.
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Three treatment comparisons from randomized trials [Delta, AIDS Clinical Trials Group (ACTG) 175, Community Programs for Clinical Research on AIDS (CPCRA) 007 and ACTC 320] were mimicked in cohorts: (i) zidovudine monotherapy versus combination regimens of two nucleoside analogues; (ii) zidovudine combined with either didanosine or zalcitabine; and (iii) a dual combination versus a triple regimen including a protease inhibitor. Data for over 10 000 patients from the French Hospital Database on HIV, the EuroSIDA study and the Swiss HIV cohort study were analysed for each of the comparisons. Progression to AIDS disease or death was analysed in Cox models, adjusting for baseline differences, and results compared with randomized trials.
Haematopoietic growth factors such as granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) are effective in the treatment of AIDS-related neutropenia. G-CSF appears to be better tolerated than GM-CSF. Moreover, GM-CSF can stimulate HIV replication in the absence of antiretroviral treatment. Thus G-CSF may offer a better treatment option in some patients. Doses of up to 300 micrograms G-CSF (filgrastim) per day rapidly reverse neutropenia in most HIV-infected patients. Subsequently, normal neutrophil counts can be maintained with intermittent doses (1-7 days a week). This allows greater use of myelosuppressive agents. Recombinant human erythropoietin is well tolerated and effective in the treatment of anaemia due to zidovudine when endogenous erythropoietin levels are < or = 500 IU/l. Recombinant human erythropoietin combined with CSF also appears to be well tolerated and effective in the treatment of combined cytopenias. Other haematopoietic growth factor combinations are currently being explored.
A total of 8237 samples were analyzed. In all, 84% of the mothers ever breast-fed their children. In instances where both mother and baby received intervention, the transmission rates of HIV were higher among those who are still breast-feeding after 6 to 12 months. Disclosure, location, and mode of delivery did not have an effect on the transmission rates of HIV when both mother and baby received prophylaxis.
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We examined the effect of methadone treatment, duration of Medicaid enrollment during pregnancy, and other maternal characteristics on receipt of prenatal care by 2,254 women infected with human immunodeficiency virus (HIV) delivering a singleton in New York state from 1985 through 1990. Data were obtained from the New York State Medicaid HIV/AIDS Research Data Base and vital statistics records. Adequacy of the number of prenatal visits reported by the mother on vital statistics records was assessed with use of the Kessner Index, which adjusts for gestational age at delivery. Too few visits were reported by 65% of the study population. Illicit drug users had higher odds of having too few visits [1.64, 95% confidence interval (CI) 1.24-2.17] than methadone-treated women but the odds were similar for non-drug users and methadone-treated women (0.79, 95% CI 0.60-1.25). Women with brief Medicaid enrollment (< or = 25% of pregnancy) had 45% higher odds of having too few visits than did longer enrollees. Treatment for drug addiction and longer Medicaid enrollment during pregnancy may offer important interventions to increase prenatal care of HIV-infected women. Approaches to increase prenatal care of HIV-infected women are especially important given trials showing a reduction in vertical transmission from zidovudine treatment during pregnancy.
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Four university-based or -affiliated clinics.
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HIV infection has been associated with decline in a number of cognitive functions that are components of 'working memory'. Thus, tests of working memory that require the interaction of these components may be particularly sensitive to cognitive dysfunction that arises from HIV infection. To assess this possibility, working memory was examined in 147 HIV-seropositive (HIV+) and 38 HIV-seronegative (HIV-) males using the Reading Span Test and the Digit Span subtest from the Wechsler Memory Scale-Revised (WMS-R). Speed of information processing, a component of some working memory tasks, was assessed with a version of the Sternberg Memory Scanning task. Results indicated that symptomatic HIV+ subjects were impaired relative to HIV- control subjects on the Reading Span and Digit Span tests. Asymptomatic and mildly symptomatic HIV+ groups exhibited a trend toward impairment on these tests, and on the whole, a greater proportion of HIV+ subjects than HIV- subjects were impaired. The groups did not differ significantly in information processing speed. These results indicate that deficits in working memory are apparent in at least a subset of HIV-infected individuals. These deficits are most apparent in symptomatic HIV+ individuals, but the decline may begin during the asymptomatic phase of infection.
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These data indicate that pharmacologic variability affects antiretroviral response. Furthermore, these findings provide a framework to characterize the pharmacologic determinants of effect and quantitate their contribution to the heterogeneity in clinical response to optimize therapeutic benefit.
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Since the introduction of HAART the incidence of HIV dementia has declined and HAART seems to improve neurocognitive function in patients with HIV dementia. Currently, HIV dementia develops mainly in patients without effective treatment, though it has also been described in patients on HAART and milder HIV-associated neuropsychological impairment is still frequent among HIV-1 infected patients regardless of HAART. Elevated cerebrospinal fluid (CSF) levels of markers of neural injury and immune activation have been found in HIV dementia, but neither of those, nor CSF HIV-1 RNA levels have been proven useful as diagnostic or prognostic pseudomarkers in HIV dementia.
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Some children with perinatal HIV infection develop early progression to severe symptoms (Category C) within the first 4 years of life. Prophylactic therapy with trimethoprim-sulfamethoxazole (TMP/SMX) may affect progression by decreasing the incidence of Pneumocystis carinii pneumonia (PCP).
Upon histological examinations fetal livers and kidneys appeared normal. In contrast the maternal samples revealed structural alterations. Maternal kidneys of the three experimental groups exhibited progressive and dose-dependent histological alterations; liver alterations were detected only in Exp3. Blood levels of AST and ALT were not significantly different from the control group but urea and creatinine levels were lower in groups Exp3 and Exp1.
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Thirty-six (43%) parents described moderate (n = 30) or great (n = 6) interference with everyday life. This was more frequent among parents of children whose HIV disease progressed (P = 0.03, Fisher's exact test) but was unrelated to ethnicity, country of origin, treatment allocated or adverse events. Invited comments suggested that concern about forgetting doses and the taste/volume of the trial medication contributed to interference with everyday life. Seventy-six (90%) parents considered information received during the trial adequate. The eight expressing dissatisfaction were recruited in the same country and five of them were among the eight (10%) who stated that they would not want to enroll their child in another trial.