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We randomized (1:1:1) 150 treatment-naive Thai HIV-infected adults with CD4(+) T-cell count <350 cells/mm(3) to arm 1 (24-week GPO-VIR S30(®) [d4T plus lamivudine (3TC) plus nevirapine (NVP)] followed by 48-week GPO-VIR Z250(®) [AZT plus 3TC plus NVP]), arm 2 (72-week GPO-VIR Z250(®)) or arm 3 (72-week TDF plus emtricitabine [FTC] plus NVP). Haemoglobin (Hb), dual energy x-ray absorptiometry, neuropathic signs, estimated glomerular filtration rate (eGFR), CD4(+) T-cell count, plasma HIV RNA and adherence were assessed.
Among 1,166 patients (65.8% female), 22.2% (95%CI: 19.3-25.3) of women and 6.3% (4.1-9.1) of men met the IDF definition of MetS (p<0.001). In both sexes, there was no significant difference in MetS prevalence between NNRTIs. However, in women taking zidovudine as NRTI MetS prevalence was 27.9%, vs. 18.8% in those taking tenofovir. In the multivariate logistic regression allowing for socio-demographic and clinical covariates, ART containing zidovudine was associated with MetS in women (aOR 2.17 (1.46-3.22), p<0.001) but not in men.
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Three oral ZDV doses were used: 1000 mg (nine patients), 750 mg (eight patients) and 500 mg (13 patients) per day, depending on haematological status.
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To evaluate the sensitivity and specificity of RNA and DNA polymerase chain reaction (PCR) for early diagnosis of perinatal HIV-1 infection and to investigate early viral dynamics in infected infants.
Retrospective evaluation of subjects enrolled in a natural history study. Two analyses were made to evaluate the effect of (1) current ZDV, irrespective of length of treatment and (2) long-term ZDV treatment for at least 1 year.
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The most important variables in the model were voluntary HIV testing, the deterrence rate associated with mandatory testing compared with voluntary testing, and the prevalence of HIV infection in women of child-bearing age. At high levels of acceptance of voluntary HIV testing, the benefits of a policy of mandatory testing are minimal and may create the potential harms of avoiding prenatal care to avoid mandatory testing.
HBsAg-positive patients are at significantly increased risk of adverse clinical outcomes after starting ART. Further studies are warranted to evaluate whether these risks remain now that tenofovir is becoming routinely available in Ghana.
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Data from recently announced virology studies show that monotherapy of any kind is not an adequate treatment for HIV disease. Preliminary results of AZT, ddI, ddC, and d4T and ddI combinations are examined, as are hydroxyurea and ddI combinations. Results show that combination therapies are having a positive effect on reducing viral load, reducing disease progression, and enhancing patient survivability. It is now believed that combination therapies that include a protease inhibitor are likely to become a recommended standard of care in the near future. Preliminary studies of two new drugs, BW-1592 (Glaxo Wellcome) and bis-POM PMEA (Gilead Sciences), are highlighted.
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Study aim was to estimate the rate and identify predictors of discontinuation of first combination antiretroviral therapy (cART) in recent years.
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9-[2-(Phosphonomethoxy)ethyl]adenine (PMEA) is an acyclic nucleotide with potent in vitro activity against human immunodeficiency virus type 1 (HIV-1). The present study was undertaken to determine whether HIV-1 resistance to PMEA could be generated by in vitro selection and if so, to determine which mutations in reverse transcriptase (RT) were responsible. HIV-1LAI was serially passaged for 10 months in the presence of increasing concentrations of PMEA up to a maximum of 40 microM. After 40 passages, the 50% inhibitory concentration (IC50) of PMEA had increased almost 7-fold from 4.45 to 30.5 microM. Some cross-resistance to 2',3'-dideoxycytidine (ddC, zalcitabine), 2',3-dideoxyinosine (ddI, didanosine), and 3'-thiacytidine (3TC, lamivudine) was also observed, but no cross-reactive resistance to 3'-azido-3'-thymidine (AZT, zidovudine). Sequencing of the RT encoding region of each of eight pol clones from resistant isolates revealed a Lys-65-->Arg (K65R) substitution. HIV with the K65R mutation inserted by site-directed mutagenesis also had decreased sensitivity to PMEA in H9 cells and a similar cross-resistance profile. Thus, HIV can develop decreased sensitivity to PMEA after long-term in vitro exposure and this change is associated with a K65R substitution. Additional studies will be needed to determine whether a similar mutation in HIV RT develops in patients receiving PMEA or its orally bioavailable prodrug adefovir dipivoxil (bis-POM PMEA).
To evaluate the impact of a first-line lopinavir/ritonavir alone or standard triple combination on HIV-1 shedding in the genital tract.
In perinatally infected infants, HIV-1 RNA levels are high and decline only slowly during the first two years of life. Infants with very high viral loads in the first months of life are at increased risk for a rapid progression of disease, which suggests that early treatment with antiretroviral agents may be indicated for these infants.
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Blinded crossover trial with controls for the protein and diluent components of the drug preparation.
We report here the results of studies examining the ability of zidovudine (AZT) to influence the establishment and maintenance of long-term marrow cultures (LTMC) using marrow from murine immunodeficient mice (MAIDS). Normal C57BL6 mice were infected with LP-BM5 (MuLV) immunodeficiency virus (10 micrograms total protein) intraperitoneally. Five weeks after viral infection, mice were sacrificed and marrow was harvested from normal non-virus-infected and virus-infected animals. LTMC were established in the presence or absence of dose escalation of AZT, that is, 10(-6), 5 x 10(-7), and 10(-7) M in vitro. Compared with controls prepared from normal bone marrow, LTMC using MAIDS-infected marrow failed to establish and subsequently release supernatant-derived mononuclear cells. The addition of AZT was ineffective in either establishing LTMC or consistently producing mononuclear cells. Measurements of erythroid (BFU-E), myeloid (CFU-GM), and megakaryocyte (CFU-Meg) precursors were all depressed and none were observed after 5 weeks of culture. Treatment with AZT failed to reverse this depression of stem cell progenitors. Microscopic examination of cultures at 10 weeks demonstrated a failure of MAIDS-LTMC to establish an adequate stromal layer compared to LTMC prepared form non-virus-infected controls. This data indicate that LP-BM5 MuLV infection alters the establishment of a normal functioning hematopoietic microenvironment or stroma. Acknowledging that important differences between MAIDS and human AIDS exist, the implications of these findings concerning the establishment of the immunodeficiency disease state in human immunodeficiency virus infection is discussed.
A total of 121 HIV-infected patients with CD4+ cell counts < or = 200 x 10(6)/l or an AIDS diagnosis were enrolled in a controlled study of aerosolized pentamidine as primary PCP prophylaxis. Patients were randomly assigned to treatment (n = 61) with aerosolized pentamidine once every month or to no treatment (n = 60). Patients were evaluated for PCP, mortality, morbidity and progression of HIV disease. Morbidity was estimated from the number of days patients were unable to work due to illness, number of days hospitalized and AIDS events.
Week 24 virologic outcomes were similar between NOAR- and HAART-treated participants, but NOAR durability was poorer and their use was associated with less immunologic reconstitution. NOARs should play a limited role in pediatric and adolescent antiretroviral therapy.
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To compare changes in quality of life (QoL) over 96 weeks in patients enrolled in a triple-therapy protocol, a treatment-intensification protocol, or an induction-maintenance therapy protocol, and to compare QoL between patients who continued and discontinued their antiretroviral regimen.
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Clinical and radiological improvement.
Of the 852 patients (161 on zidovudine [ZDV], 628 on stavudine [d4T], and 63 on tenofovir [TDF]; all received lamuvidine), the risk of developing grade 4 anemia was higher (adjusted hazard ratio 2.7) for those receiving ZDV than those receiving d4T. Those receivingd4T had a higher average increase in Hb than those receiving ZDV (P = .024) or TDF (P = .014).
Ensuring that no baby is born with HIV is an essential step towards achieving an AIDS-free generation. To achieve this, strategies that decouple links between childbirth and HIV transmission are necessary. Traditional forms of prevention of mother-to-child transmission of HIV (PMTCT), has been recommended. Recognizing the importance and challenges of combination of methods to achieve rapid PMTCT, the World Health Organization (WHO) recommended option B Highly Active Antiretroviral Therapy (HAART) for all HIV-positive pregnant women. This study aimed to evaluate the effectiveness of the HAART in PMTCT. A cohort of HIV-infected pregnant women in Kenya were obtained from the DREAM Center, Nairobi. The study participants underwent adherence counselling and Option B of HAART [Nevirapine(NVP) + Lamivudine + Zidovudine] at the fourth week of gestation followed by an intravenous NVP administration intrapartum and postpartum NVP syrup to the respective infants for six weeks. Absolute pre-HAART and post-HAART CD4 counts and viral loads counts were determined. Comparison of the CD4 counts and viral loads before and after administration of HAART were done using Wilcoxon's Matched Pairs Signed-Ranks Test.
When considering alternative treatments for HIV infection it is important to first gather as much information on the treatment as possible. It was emphasized at the Fifth Annual Statewide HIV/AIDS Policy Conference that alternative medicine can be used to complement traditional medicine, such as helping the body handle some of the toxic side effects of AZT. There was skepticism about alternative medicines due to lack of knowledge and an unwillingness to learn about them. Patients need to communicate their interest in alternative practices with their doctors and request that their blood be closely monitored. Factors to consider when looking at alternative therapies are cost, convenience, and information availability and quality. Most alternative treatments have not been in clinical trials, therefore, information will need to be gathered through various sources, not just the company's sales pitch. One's doctor should be informed of the additional uses of alternative medicine so the doctor can look for interactions and positive/negative results.
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We assessed the 96-week effects on lipids, adverse events (AEs), and body fat distribution (dual-energy x-ray absorptiometry) of rilpivirine (RPV) and EFV plus 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in treatment-naive adults infected with human immunodeficiency virus type 1 (HIV-1).
It has become apparent that the beneficial effects of zidovudine (AZT) and other antivirals will not continue indefinitely. However, synergistic activity of lamivudine (3TC) in combination with AZT, as well as reversal of phenotypic AZT resistance due to the presence of 3TC resistance-inducing mutations, has been documented in vitro. Two trials (NUCB 3001 and NUCB 3002) are therefore investigating the potential of the combination of 3TC with AZT. HIV-1-positive patients with CD4 cell counts of 100-400 cells/mm3 who had not previously received AZT were enrolled into study NUCB 3001 and treated with either AZT (200 mg t.i.d.) or 3TC (300 mg b.i.d.) plus AZT (200 mg t.i.d.) for 24 weeks. Open-label treatment with the combination regimen was offered for an additional 24 weeks. Both treatment groups experienced an initial increase in CD4 cell count. This increase was significantly greater and more sustained in the combination treatment group than in those receiving AZT monotherapy. Participants originally receiving AZT monotherapy, who changed to combination therapy after 24 weeks, experienced a rise in CD4 count. Those who began the study receiving combination therapy maintained their increased CD4 count for the duration of the study. A statistically significant difference in CD4 cell count between the two treatment groups was observed over the entire 48-week treatment period (p = 0.0001) indicating that initial combination therapy was superior to monotherapy followed by a switch combination therapy after 24 weeks. Both treatment groups experienced a reduction in HIV-RNA levels and cellular viraemia, but these reductions were significantly greater in the combination treatment group than in those receiving AZT monotherapy. In addition, among patients initially randomized to AZT monotherapy, a significant reduction in the viral RNA concentration was observed after switching to combination therapy at week 24. There was an 80% reduction in p24 antigen levels from baseline in the combination treatment group compared with a 34% reduction from the baseline in the AZT monotherapy group, at 24 weeks. HIV-1-positive patients with CD4 cell counts of 100-400 cells/mm3 who had previously received a minimum of 24 weeks AZT treatment were enrolled into study NUCB 3002 and received either AZT monotherapy (200 mg t.i.d. plus placebo); AZT (200 mg t.i.d.) plus 3TC (300 mg b.i.d.) or AZT (200 mg t.i.d.) plus 3TC (150 mg b.i.d.) for 24 weeks. Open-label treatment with 3TC plus optional AZT was offered for a further 24 weeks (open-label phase). The study is still ongoing, but an initial increase in CD4 cell count was observed in the combination groups whereas, in the AZT monotherapy group, no discernible increase in CD4 cell count was observed at any time. The favorable effect of combination treatment with AZT and 3TC on CD4 cell count persisted throughout the open-label phase of the study. The addition of 3TC to the treatment regimens of patients who initially received AZT monotherapy had a favorable effect on CD4 cell count. Combination treatment with 3TC and AZT also resulted in a significantly greater reduction in viral load compared with AZT monotherapy. In conclusion, combination therapy with AZT plus 3TC produces beneficial effects on CD4 cell counts, HIV-1 RNA levels, and p24 antigen levels, which appear to be greater and more sustained than those produced by AZT monotherapy or any combination therapy to date. This combination appears to offer increased efficacy compared with AZT monotherapy without an increased risk of adverse experiences. Future studies to identify those patients most likely to benefit from such treatment and the optimum time for its initiation are therefore warranted.
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Consecutive patients with plasma human immunodeficiency virus RNA load < 200 copies/mL switching to unboosted atazanavir plus zidovudine-lamivudine (coformulated), abacavir-lamivudine (coformulated), or TDF/lamivudine > 3 months were included for determinations of treatment response, plasma atazanavir concentrations, and single-nucleotide polymorphisms of MDR1, PXR, and UGT1A1 genes from 2010 to 2014. Treatment failure was defined as either discontinuation of atazanavir for any reason or plasma viral load ≥ 200 copies/mL within 96 weeks.
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There were no significant differences in genotype frequency among the three groups analyzed. Considering the HIV-1-infected pregnant women, there were no significant differences in genotype frequency between the zidovudine group and the triple antiretroviral treatment group. There were no significant differences in allele frequencies among the groups evaluated. Non-white pregnant women tended to present the GG genotypes compared to white pregnant women.
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Reduced levels of serum carnitines (3-hydroxy-4-N-trimethyl-ammonio-butanoate) are found in most patients treated with zidovudine. However, since serum carnitines do not strictly reflect cellular concentrations we examined whether a carnitine depletion could be found in peripheral blood mononuclear cells (PBMC) from AIDS patients with normal serum carnitine levels. In addition, we explored whether it was possible to relate the host's immunoreactivity to the content of carnitine in PBMC and whether carnitine levels can be corrected by oral supplementation of L-carnitine.
Observational prospective cohort.