Drug related adverse events.

<p>VL–visceral leishmaniasis</p><p>*two of the renal impairments occurred in patients admitted for severe pneumonia who eventually died while on treatment. But as pentamidine is also known for its renal effect, they were considered as possibly pentamidine related serious adverse events</p><p>**this patient was made to discontinue the pentamidine when he developed hyperglycemia that normalized on the next month visit. These three patients (2 with renal failures and 1 with hyperglycemia) accounted for the primary safety outcome)</p><p>Drug related adverse events.</p

HIV and VL treatment history.

<p>VL–visceral leishmaniasis, ART–antiretroviral therapy, IQR–interquartile range, TDF–tenofovir, 3TC–lamivudine, EFV–efavirenze, AZT–zidovudine, NVP–nevirapine, D4T –didanosine, DDI–didanosine, ABC–abacavir, LPV/r–lopinavir/ritonavir</p><p>*Miltefosine and paromomycin were always used in combination with Liposomal amphotericin B and sodium stibogluconate respectively. Prolonged treatments with different regimens were also done until cure was achieved.</p><p>HIV and VL treatment history.</p

Use of Pentamidine As Secondary Prophylaxis to Prevent Visceral Leishmaniasis Relapse in HIV Infected Patients, the First Twelve Months of a Prospective Cohort Study

<div><p>Background</p><p>Visceral leishmaniasis (VL) has become an important opportunistic infection in persons with HIV-infection in VL-endemic areas. The co-infection leads to profound immunosuppression and high rate of annual VL recurrence. This study assessed the effectiveness, safety and feasibility of monthly pentamidine infusions to prevent recurrence of VL in HIV co-infected patients.</p><p>Methods</p><p>A single-arm, open-label trial was conducted at two leishmaniasis treatment centers in northwest Ethiopia. HIV-infected patients with a VL episode were included after parasitological cure. Monthly infusions of 4mg/kg pentamidine-isethionate diluted in normal-saline were started for 12months. All received antiretroviral therapy (ART). Time-to-relapse or death was the primary end point.</p><p>Results</p><p>Seventy-four patients were included. The probability of relapse-free survival at 6months and at 12 months was 79% and 71% respectively. Renal failure, a possible drug-related serious adverse event, occurred in two patients with severe pneumonia. Forty-one patients completed the regimen taking at least 11 of the 12 doses. Main reasons to discontinue were: 15 relapsed, five died and seven became lost to follow-up. More patients failed among those with a CD4+cell count ≤ 50cells/μl, 5/7 (71.4%) than those with counts above 200 cells/μl, 2/12 (16.7%), (p = 0.005).</p><p>Conclusion</p><p>Pentamidine secondary prophylaxis led to a 29% failure rate within one year, much lower than reported in historical controls (50%-100%). Patients with low CD4+cell counts are at increased risk of relapse despite effective initial VL treatment, ART and secondary prophylaxis. VL should be detected and treated early enough in patients with HIV infection before profound immune deficiency installs.</p></div

Kaplan-Meier survival estimate of the main effectiveness analysis.

<p>Kaplan-Meier survival estimate of the main effectiveness analysis.</p

Summary of Primary Effectiveness Analysis Results.

<p>**Survival analysis percentages take into account that some patients were censored during the follow-up, VL–visceral leishmaniasis</p><p>Summary of Primary Effectiveness Analysis Results.</p

Risk factors for relapse.

<p>VL–visceral leishmaniasis, ART–antiretroviral therapy</p><p>Risk factors for relapse.</p

Flow chart showing the recruitment process and main outcomes.

<p>Flow chart showing the recruitment process and main outcomes.</p

Baseline characteristics of recruited patients in three groups.

<p>*Not measured due to ascites, IQR–Interquartile range, bpm–beats per minute, VL–visceral leishmaniasis, WBC–white blood cells</p><p>Baseline characteristics of recruited patients in three groups.</p

The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices

<p>The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices</p

SOP template with section headings according to CLSI guideline QMS02-A6 2013 [2].

<p>SOP template with section headings according to CLSI guideline QMS02-A6 2013 [<a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0005053#pntd.0005053.ref002" target="_blank">2</a>].</p