Browsing by Author "Namakula, Rhoda"
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Item Building clinical pharmacology laboratory capacity in low- and middle-income countries: Experience from Uganda(African Journal of Laboratory Medicine, 2023) Omali, Denis; Buzibye, Allan; Kwizera, Richard; Byakika-Kibwika, Pauline; Namakula, Rhoda; Matovu, Joshua; Mbabazi, Olive; Mande, Emmanuel; Sekaggya-Wiltshire, Christine; Nakanjako, Damalie; Gutteck, Ursula; McAdam, Keith; Easterbrook, Philippa; Kambugu, Andrew; Fehr, Jan; Castelnuovo, Barbara; Manabe, Yukari C.; Lamorde, Mohammed; Mueller, Daniel; Merry, ConceptaResearch and clinical use of clinical pharmacology laboratories are limited in low- and middle-income countries. We describe our experience in building and sustaining laboratory capacity for clinical pharmacology at the Infectious Diseases Institute, Kampala, Uganda. Intervention: Existing laboratory infrastructure was repurposed, and new equipment was acquired. Laboratory personnel were hired and trained to optimise, validate, and develop in-house methods for testing antiretroviral, anti-tuberculosis and other drugs, including 10 high-performance liquid chromatography methods and four mass spectrometry methods. We reviewed all research collaborations and projects for which samples were assayed in the laboratory from January 2006 to November 2020. We assessed laboratory staff mentorship from collaborative relationships and the contribution of research projects towards human resource development, assay development, and equipment and maintenance costs. We further assessed the quality of testing and use of the laboratory for research and clinical care. Lessons learnt: Fourteen years post inception, the clinical pharmacology laboratory had contributed significantly to the overall research output at the institute by supporting 26 pharmacokinetic studies. The laboratory has actively participated in an international external quality assurance programme for the last four years. For clinical care, a therapeutic drug monitoring service is accessible to patients living with HIV at the Adult Infectious Diseases clinic in Kampala, Uganda. Recommendations: Driven primarily by research projects, clinical pharmacology laboratory capacity was successfully established in Uganda, resulting in sustained research output and clinical support. Strategies implemented in building capacity for this laboratory may guide similar processes in other low- and middle-income countries.Item Nevirapine pharmacokinetics when initiated at 200 mg or 400 mg daily in HIV-1 and tuberculosis co-infected Ugandan adults on rifampicin(Journal of Antimicrobial Chemotherapy, 2011) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Okaba-Kayom, Violet; Ryan, Mairin; Coakley, Peter; Boffito, Marta; Namakula, Rhoda; Kalemeera, Francis; Colebunders, Robert; Back, David; Khoo, Saye; Merry, ConceptaIn resource-poor countries, HIV and tuberculosis (TB) co-infection results in significant morbidity and mortality. Co-treatment is recommended by the WHO;1 however, drug interactions are common between anti-TB regimens containing rifampicin and antiretroviral drugs. In these settings, rifampicin is a key drug for TB treatment because alternative rifamycins are more expensive and usually not available in public TB control programmes. Similarly, for HIV treatment, only a limited number of antiretroviral drugs are routinely used. The problems arising from limited drug options are compounded by the wide use of fixed-dose combination (FDC) formulations for both diseases. When these formulations are used, drug substitutions are not possible and dose adjustments are usually difficult.Item Significant pharmacokinetic interactions between artemether/lumefantrine and efavirenz or nevirapine in HIV-infected Ugandan adults(Journal of Antimicrobial Chemotherapy, 2012) Byakika-Kibwika, Pauline; Lamorde, Mohammed; Mayito, Jonathan; Nabukeera, Lillian; Namakula, Rhoda; Mayanja-Kizza, Harriet; Katabira, Elly; Ntale, Muhammad; Pakker, Nadine; Ryan, Mairin; Hanpithakpong, Warunee; Tarning, Joel; Lindegardh, Niklas; Vries, Peter J. de; Khoo, Saye; Back, DavidCo-administration of artemether/lumefantrine with antiretroviral therapy has potential for pharmacokinetic drug interactions. We investigated drug–drug interactions between artemether/lumefantrine and efavirenz or nevirapine. Methods: We performed a cross-over study in which HIV-infected adults received standard six-dose artemether/ lumefantrine 80/480 mg before and at efavirenz or nevirapine steady state. Artemether, dihydroartemisinin, lumefantrine, efavirenz and nevirapine plasma concentrations were measured and compared.Item Suboptimal Nevirapine Steady-State Pharmacokinetics During Intrapartum Compared With Postpartum in HIV-1–Seropositive Ugandan Women(Journal of acquired immune deficiency syndromes, 2010) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Okaba-Kayom, Violet; Flaherty, John P.; Boffito, Marta; Namakula, Rhoda; Ryan, Mairin; Nakabiito, Clemensia; Back, David J.; Khoo, Saye; Merry, Concepta; Scarsi, Kimberly K.Conflicting data exist regarding the effect of pregnancy on steady-state nevirapine pharmacokinetics (PK), although steady-state nevirapine concentrations during pregnancy have never been characterized in sub-Saharan Africa. Methods: This was a longitudinal intensive PK study in Ugandan pregnant women receiving nevirapine-based antiretroviral therapy. Participants underwent intensive 12-hour PK sampling during the second trimester (T2; n = 4), third trimester (T3; n = 15) and 6 weeks postpartum (PP; n = 15). HIV-1 RNAwas performed within 2weeks of each visit. Nevirapine C12 above 3000 ng/mLwas classified as optimal based on the suggested value for therapeutic drug monitoring.