Trial reportJournal of clinical pharmacology2014
Pharmacokinetics of lopinavir/ritonavir and efavirenz in food insecure HIV-infected pregnant and breastfeeding women in Tororo, Uganda.
Trial report in Journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00993031 (Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women), which is not on this map. Cited by 37 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Who cites it
37 citing papers in PubMed, 6 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- HIV Infections and Food Insecurity Among Pregnant Women from Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.AIDS and behavior · 2021Pooled it
- Influence of Malnutrition on the Pharmacokinetics of Drugs Used in the Treatment of Poverty-Related Diseases: A Systematic Review.Clinical pharmacokinetics · 2021Pooled it
- Household food insecurity associated with gestacional and neonatal outcomes: a systematic review.BMC pregnancy and childbirth · 2020Pooled it
- Antiretroviral Concentration in Hair as a Measure for Antiretroviral Medication Adherence: A Systematic Review of Global Literature.AIDS and behavior · 2020Pooled it
- Food insecurity, sexual risk behavior, and adherence to antiretroviral therapy among women living with HIV: A systematic review.Health care for women international · 2017Pooled it
- Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review.PLoS medicine · 2016Pooled it
- Trial
- Trial
- Comprehensive Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Evaluation of Once-Daily Efavirenz 400 and 600 mg in Treatment-Naïve HIV-Infected Patients at 96 Weeks: Results of the ENCORE1 Study.Clinical pharmacokinetics · 2016Trial
- Brief Report: Food Insufficiency Is Associated With Lack of Sustained Viral Suppression Among HIV-Infected Pregnant and Breastfeeding Ugandan Women.Journal of acquired immune deficiency syndromes (1999) · 2016Trial
- Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.AIDS (London, England) · 2015Trial
- Trial
- Novel application of dried blood spot tenofovir diphosphate to predict viral suppression in postpartum women with HIV in Malawi.AIDS (London, England) · 2026Article
- Pharmacokinetic Adaptations in Pregnancy: Implications for Optimizing Antiretroviral Therapy in HIV-Positive Women.Pharmaceutics · 2025Review
- Social, economic and food insecurity among people living with HIV in Kenya during coinciding public health and environmental emergencies: a mixed-methods study.BMJ public health · 2024Article
- Associations between food insecurity and child and parental physical, nutritional, psychosocial and economic well-being globally during the first 1000 days: A scoping review.Maternal & child nutrition · 2024Article
- Pharmacokinetics of Antidepressants in Pregnancy.Journal of clinical pharmacology · 2023Review
- Lopinavir and tenofovir interaction observed in non-pregnant adults altered during pregnancy.Journal of clinical pharmacy and therapeutics · 2021Article
- Exclusive breastfeeding among HIV exposed infants from birth to 14 weeks of life in Lira, Northern Uganda: a prospective cohort study.Global health action · 2020Article
- Piperaquine Exposure Is Altered by Pregnancy, HIV, and Nutritional Status in Ugandan Women.Antimicrobial agents and chemotherapy · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 4 institutions in 2 countries.
Funding
Abstract
Pregnancy and food insecurity may impact antiretroviral (ART) pharmacokinetics (PK), adherence and response. We sought to quantify and characterize the PK of lopinavir/ritonavir (LPV/r) and efavirenz (EFV) by pregnancy and nutritional status among HIV-infected women in Tororo, Uganda. In 2011, 62/225 ante-partum/post-partum single dried blood spot samples DBS and 43 post-partum hair samples for LPV/r were derived from 116 women, 51/194 ante-/post-partum DBS and 53 post-partum hair samples for EFV from 105 women. Eighty percent of Ugandan participants were severely food insecure, 26% lost weight ante-partum, and median BMI post-partum was only 20.2 kg/m(2) . Rich PK-data of normally nourished (pregnant) women and healthy Ugandans established prior information. Overall, drug exposure was reduced (LPV -33%, EFV -15%, ritonavir -17%) compared to well-nourished controls (P < 0.001), attributable to decreased bioavailability. Pregnancy increased LPV/r clearance 68% (P < 0.001), whereas EFV clearance remained unchanged. Hair concentrations correlated with plasma-exposure (P < 0.001), explaining 29% PK-variability. In conclusion, pregnancy and food insecurity were associated with lower ART exposures in this cohort of predominantly underweight women, compared to well-nourished women. Much variability in plasma-exposure was quantified using hair concentrations. Addressing malnutrition as well as ART-PK in this setting should be a priority.
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Registered trials
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