In order to decide whether the rabbit method or the rhesus monkey test is better suited for routine vaginal tolerance tests of spermicidal preparations, combined trials employing both techniques were carried out in the two laboratories in which the tests had been developed.A`double-blind' experimental design was used in which three unknown, coded compounds were tested jointly in both laboratories and evaluated independently and reciprocally after transatlantic exchange of the resulting histological material. Both test methods and the scoring systems employed in the assessment of findings are described and illustrated by representative photomicrographs.There was good agreement between both methods for two of the three preparations tested. For the third preparation, the rabbit test results were more consistent with the available clinical data than those of the monkey test.It was concluded that the rabbit technique is more sensitive than the monkey test. Since it has several obvious practical advantages over the latter, it is proposed that the rabbit vagina test should be generally adopted as the standard method for establishing the local tolerance of new spermicidal preparations for vaginal use.

BackgroundA few case reports have noted uncontrolled hyperglycemia in patients switched to dolutegravir. Several cohort studies have found increased weight gain among patients treated with integrase inhibitors (INSTI). We present clinical observations among 3 patients admitted to hospital for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) while receiving INSTIs for the management of HIV.MethodsCase 1: A 44-year-old man with HIV and dyslipidemia presented with altered mental status and lethargy. A fingerstick glucose was >600 mg/dL. Chemistries revealed glucose of 1,600 mg/dL and an elevated β-hydroxybutyrate. HbA1c was 12.4%. His antiretroviral regimen consisted of cEVG/TAF/FTC for the last 3 years. Previous HbA1c levels were 5.7% and 6.2% (Figure 1). Case 2: A 55-year-old woman with HIV, hypertension, dyslipidemia, and obesity presented with polyuria and polydipsia. The blood glucose level was >1,200 mg/dL with an anion gap >30 and HbA1c of 15%. Previous HbA1c levels ranged between 5.6 and 5.8% (Figure 2). She had been taking ABC/FTC/DTG for 2 years.Case 3: A 64 yo man with a history of HIV, hypertension, and obesity presented with polyuria and polydipsia. The blood glucose level was 1,152 mg/dL with no anion gap and HbA1c of 13.4%. Six months before, he had been switched from a c/DRV- based ART regimen to ABC/FTC/DTG. Previous HbA1c levels ranged between 5.8% and 6.2% (Figure 3).ResultsDiscussion: In the first 2 patients, the presentation with acute onset DKA occurred more than a year after being on an INSTI-based regimen; however, the latter patient presented with HHS within 6 months of being switched to an INSTI-containing regimen. The mechanism of action of INSTIs causing weight gain or an association with hyperglycemia is still under investigation.ConclusionAlthough the temporal onset of DKA and HHS while receiving INSTIs was not precise, the possible association of INSTIs and their direct effects on insulin resistance and diabetes warrant additional attention from post-market data. Meanwhile, providers should monitor INSTI-treated patients closely, especially those with features of metabolic syndrome. Disclosures All authors: No reported disclosures.

Background: Persons with HIV (PWH) have normal life expectancy on antiretroviral therapy (ART), but a rising burden of type 2 diabetes mellitus (DM) disproportionately affecting women and Black individuals threatens these gains. We therefore assessed whether disparities in DM incidence are reflected in disease screening and treatment by HIV providers. Methods: PWH on ART with ≥2 clinic visits at a large HIV clinic in the southeast from 2007-2022 contributed data, if they did not have prevalent DM at enrollment: existing ICD-9/10 diagnoses of DM, antidiabetic medication, hemoglobin A1c (A1c) ≥6.5%, or random glucose ≥200 mg/dL. We assessed the association of demographic and clinical factors with DM screening by A1c and, among those with incident DM by A1c or ICD-9/10 diagnosis or random glucose, DM treatment and achievement of goal (i.e., A1c ≤7.0%). For each “care continuum” step, we used modified Poisson regression to estimate adjusted incidence rate ratios (IRRs) of reaching the next step by these factors. Results: Among 5450 PWH enrolling, 3762 (69%) were screened for DM by A1c, of whom 1001 (27%) had dysglycemia (A1c >5.7%) and 162 (4.3%) were diagnosed with DM. Among 186 PWH with incident DM, 136 (73%) initiated antidiabetic medication and 94 (84%) achieved an A1c ≤7.0%. Older, Black, and overweight or obese PWH were more likely to be screened (IRRs=1.0-1.1, p<0.05 each) and diagnosed with DM (IRRs=1.8-2.8, p<0.05 each), but there was no significant sex difference in the adjusted model. Of those screened and diagnosed with DM, no clinical or demographic factors were associated with DM treatment initiation or achieving A1c goal. Conclusions: Older, Black, and overweight/obese PWH were more likely to be screened for and diagnosed with DM. However, we found no disparities in initiating DM medications or achieving an A1c goal. While DM screening among PWH warrants improvement, women and Black PWH, two groups with a higher risk of DM, did not appear to be treated disparately in this population. Disclosure N.Millman: None. J.Koethe: Advisory Panel; Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., Gilead Sciences, Inc., Theratechnologies, Research Support; Merck Sharp & Dohme Corp. M.Turner: None. K.Bourgi: Advisory Panel; Gilead Sciences, Inc., Theratechnologies, Research Support; Gilead Sciences, Inc. T.Sterling: None. P.Rebeiro: Consultant; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Research Support; National Institutes of Health. Funding National Institutes of Health (P30AI110527)

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