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Median CD4 Count (median + cd4_count)
Selected AbstractsAntiviral activity of low-dose alovudine in antiretroviral-experienced patients: results from a 4-week randomized, double-blind, placebo-controlled dose-ranging trial,HIV MEDICINE, Issue 3 2007J Ghosn Background Alovudine inhibits replication of highly nucleoside reverse transcriptase inhibitor (NRTI)-resistant HIV strains in vitro. However, dose-dependent safety concerns resulted in its initial development being halted. Recently, a 4-week course of alovudine 7.5 mg/day added to a stavudine-free failing regimen yielded a significant decrease in viral load by ,1.88 log10 HIV-1 RNA copies/mL. The magnitude of the reduction in viral load suggested that lower doses might still be effective while offering adequate safety during long-term use. Objective To determine whether lower dosages of alovudine still provide significant antiviral activity in patients with broad NRTI resistance. Methods A randomized, double-blind, placebo-controlled trial investigating three doses of alovudine (0.5, 1 and 2 mg) or placebo added for 4 weeks to a failing regimen in patients with evidence of NRTI-resistant HIV strains [,2 thymidine-associated mutations (TAMs)]. The primary endpoint was the mean viral load reduction between baseline and week 4. Results Seventy-two patients were enrolled in the study: 21, 13, 18 and 20 in the placebo and 0.5, 1 and 2 mg arms, respectively. Baseline median CD4 count and viral load were 298 cells/,L (range 44,692 cells/,L) and 3.9 log10 copies/mL (range 2.5,5.2 log10 copies/mL), respectively. Baseline viral isolates harboured a median of four TAMs. Alovudine was added to a median four-drug failing regimen. At week 4, compared with placebo, mean viral load changes were ,0.42 log10 [95% confidence interval (CI) ,0.67 to ,0.18] and ,0.30 log10 (,0.55 to ,0.06) in the 2 and 1 mg arms, respectively. There was no significant change in CD4 cell count. Alovudine was well tolerated. Conclusion: A 4-week course of alovudine 2 mg/day provided a modest but significant viral load reduction in patients harbouring viruses with a median of four TAMs. [source] Extended antiretroviral treatment interruption in HIV-infected patients with long-term suppression of plasma HIV RNAHIV MEDICINE, Issue 1 2005CJ Achenbach Objectives Evaluation of extended treatment interruption (TI) in chronic HIV infection among patients successfully treated with antiretroviral therapy. Methods An observational analysis of 25 patients in a prospectively followed cohort with chronic HIV infection, viral loads <500 HIV-1 RNA copies/mL for at least 6 months, and an interruption in therapy of ,28 days duration was carried out. Follow up was divided into 3-month time periods for analysis. The effects of time period, stratification group and stratification group by time period interactions on CD4 counts were tested using a mixed model. Univariate comparisons among patient characteristics and responses were performed using Fisher's exact test or the Wilcoxon rank sum test. Results At initiation of TI, the median CD4 count was 799 cells/,L. TI duration was a median of 7.1 months. HIV RNA rebounded to a median maximum level of 75 000 copies/mL. Maximum viral rebound was significantly greater in patients who were male, had lipodystrophy and had zenith HIV RNA prior to TI of ,50 000 copies/mL. Lower CD4 cell counts were observed during TI in patients with lipodystrophy, zenith HIV RNA ,50 000 copies/mL, history of AIDS, HIV infection ,5 years and presuppression CD4 count ,350 cells/,L. Patients who reinitiated therapy had shorter TI duration, presuppression CD4 count ,350 cells/,L, previous AIDS diagnosis and lipodystrophy. No patients developed adverse or AIDS-defining events during TI. Conclusions Long-term TI resulted in greater immune deterioration in patients with high viral set points or low CD4 cell counts prior to initiation of suppressive antiretroviral therapy. [source] HIV-related morbidity and mortality in patients starting protease inhibitors in very advanced HIV disease (CD4 count of <,50 cells/無): an analysis of 338 clinical events from a randomized clinical trial,HIV MEDICINE, Issue 2 2002M Floridia Background AIDS defining events occur infrequently in the presence of CD4 counts above 200 cells/無. It is, however, uncertain for most of the AIDS defining conditions whether this threshold can be considered equally safe in patients with a previously very low CD4 nadir. Methods We evaluated in detail all the AIDS defining events observed during a 48-week clinical trial in 1251 nucleoside reverse transcriptase inhibitor-experienced patients who started protease inhibitors (PIs) at CD4 counts below 50 cells/無. The type of event, immunological status at the moment of event and time between start of PI treatment and event occurrence were analysed cumulatively and by event type; event rates were calculated. Results Concomitant data on CD4 counts were available for 338 AIDS defining events (81% of total events). Median time between start of treatment with PI and event was 94.5 days and median absolute CD4 value at the occurrence of event was 20 per 無. Only 14 events (in 12 patients) were observed above the threshold of 200 CD4 cells/無. An analysis of the 67 deaths with concomitantly available CD4 counts (57%) showed a median CD4 count of 10 cells/無, with only four deaths occurring in the presence of a CD4 count above 100 cells/無. Conclusions Very few clinical AIDS defining conditions were observed in patients who start PIs at very low CD4 counts and with treatment restore absolute values in CD4 counts above 200 cells/無. This threshold can therefore be considered a clinically effective goal of treatment with respect to occurrence of all AIDS defining conditions in patients starting PIs in very advanced HIV disease. [source] Response to pegylated interferon plus ribavirin in HIV-infected patients with chronic hepatitis C due to genotype 4JOURNAL OF VIRAL HEPATITIS, Issue 10 2008L. Mart璯-Carbonero Summary., Hepatitis C virus (HCV) genotypes 1 and 4 respond less well to pegylated interferon (pegIFN) plus ribavirin (RBV) therapy. For this reason most studies merge these two genotypes when assessing virological response. However, in most trials the HCV genotype 4 population is rather small, and conclusions are mainly derived from what occurs in HCV-1 patients. All HCV-4 patients coinfected with HIV who received pegIFN plus RBV in two different multicentre studies, PRESCO and ROMANCE, conducted respectively in Spain and Italy, were retrospectively analyzed. Baseline plasma HCV-RNA, proportion of patients with HCV-RNA <10 IU,/,mL at week 4 (rapid virological response), and HCV-RNA declines >2 logs at week 12 (early virological response, EVR) were all assessed as predictors of sustained virological response (SVR). Overall, 75 patients (60 men) were evaluated. Median age was 40 years and median CD4 count 598 cells,/,mm3; 49% had plasma HIV-RNA <50 copies,,/,,mL; 71% had elevated liver enzymes and 31% had advanced liver fibrosis (Metavir F3,F4). Median serum HCV-RNA was 5.7 log IU,/,mL. Rapid virological response was attained by 10 (20%) patients and EVR by 26 (42%). Using intention-to-treat and on-treatment (OT) analyses, SVR was achieved by 21,/,75 (28%) and 21,/,62 (34%) of HCV-4 patients, respectively. In the multivariate analysis (OT), baseline HCV-RNA (OR 0.09 for every log increment; 95% CI: 0.01,0.7) and EVR (OR: 7.08; 95% CI: 1.8,27.2) were significantly and independently associated with SVR. This is the largest series of HIV-infected patients with chronic hepatitis C due to HCV-4 treated with pegIFN plus RBV examined so far and the results show that HCV-4 behaves similarly to HCV-1. Therefore, these patients should be considered as difficult to treat population. Baseline serum HCV-RNA and EVR are the best predictors of SVR in HCV-4,/,HIV-coinfected patients. [source] The Vermont Model for Rural HIV Care Delivery: Eleven Years of Outcome Data Comparing Urban and Rural ClinicsTHE JOURNAL OF RURAL HEALTH, Issue 2 2010Christopher Grace MD Abstract Context: Provision of human immunodeficiency virus (HIV) care in rural areas has encountered unique barriers. Purpose: To compare medical outcomes of care provided at 3 HIV specialty clinics in rural Vermont with that provided at an urban HIV specialty clinic. Methods: This was a retrospective cohort study. Findings: Over an 11-year period 363 new patients received care, including 223 in the urban clinic and 140 in the rural clinics. Patients in the 2 cohorts were demographically similar and had similar initial CD4 counts and viral loads. There was no difference between the urban and rural clinic patients receiving Pneumocystis carinii prophylaxis (83.5% vs 86%, P= .38) or antiretroviral therapy (96.8% vs 97.5%, P= .79). Both rural and urban cohorts had similar decreases in median viral load from 1996 to 2006 (3,876 copies/mL to <50 copies/mL vs 8,331 copies/mL to <50 copies/mL) and change in percent of patients suppressed to <400 copies/mL (21.4%-69.3% vs 16%-71.4%, P= .11). Rural and urban cohorts had similar increases in median CD4 counts (275/mm3 -350/mm3 vs 182 cells/mm3 -379/mm3). A repeated measures regression analysis showed that neither fall in viral load (P= .91) nor rise in CD4 count (P= .64) were associated with urban versus rural site of care. Survival times, using a Cox proportional hazards model, were similar for urban and rural patients (hazard ratio for urban = 0.80 [95% CI, 0.39-1.61; P= .53]). Conclusions: This urban outreach model provides similar quality of care to persons receiving care in rural areas of Vermont as compared to those receiving care in the urban center. [source] | ||||||||||