Trial reportJournal of acquired immune deficiency syndromes (1999)2018
Pre-exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Kidney Tubular Dysfunction in HIV-Uninfected Individuals.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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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.
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Who cites it
16 citing papers in PubMed, 28 citations in OpenAlex.
- Trial
- Cytogenetic changes in oral mucosa cells from individuals submitted to oral human immunodeficiency virus pre-exposure prophylaxis use.Revista da Associacao Medica Brasileira (1992) · 2023Trial
- Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus.The Journal of antimicrobial chemotherapy · 2022Trial
- Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate - emtricitabine for HIV pre-exposure prophylaxis.Journal of the International AIDS Society · 2020Trial
- Biomarkers for Chronic Kidney Disease: An Updated Review of Innovative Detection Approaches.Current aging science · 2026Review
- Effect of antiretrovirals on renal function in people taking HIV pre-exposure prophylaxis.Revista latino-americana de enfermagem · 2025Article
- Integration of High-Throughput Imaging and Multiparametric Metabolic Profiling Reveals a Mitochondrial Mechanism of Tenofovir Toxicity.Function (Oxford, England) · 2023Article
- HIV, STI and renal function testing frequency and STI history among current users of self-funded HIV pre-exposure prophylaxis, a cross-sectional study, Germany, 2018 and 2019.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2022Article
- Prevalence and predictors of renal dysfunction among people living with HIV on antiretroviral therapy in the Southern Highland of Tanzania: a hospital-based cross-sectional study.The Pan African medical journal · 2022Article
- The Promise of Tubule Biomarkers in Kidney Disease: A Review.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021Review
- Associations of CKD risk factors and longitudinal changes in urine biomarkers of kidney tubules among women living with HIV.BMC nephrology · 2021Article
- Tenofovir and emtricitabine concentrations in hair are comparable between individuals on tenofovir disoproxil fumarate versus tenofovir alafenamide-based ART.Drug testing and analysis · 2021Article
- Development and Validation of an Up-to-Date Highly Sensitive UHPLC-MS/MS Method for the Simultaneous Quantification of Current Anti-HIV Nucleoside Analogues in Human Plasma.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.Current HIV/AIDS reports · 2020Review
- HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine and changes in kidney function and tubular health.AIDS (London, England) · 2020Article
- Distinct Dimensions of Kidney Health and Risk of Cardiovascular Disease, Heart Failure, and Mortality.Hypertension (Dallas, Tex. : 1979) · 2019Article
Corrections and comments
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Authors and funding
12 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundPre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is becoming increasingly adopted for HIV prevention. Tenofovir can cause proximal tubular damage and chronic kidney disease in HIV-infected persons, but little is known regarding its nephrotoxic potential among HIV-uninfected persons. In this study, we evaluated the effects of PrEP on urine levels of the following: α1-microglobulin (α1m), a marker of impaired tubular reabsorption; albuminuria, a measure of glomerular injury; and total proteinuria.
settingThe Iniciativa Profilaxis Pre-Exposicion (iPrEx) study randomized HIV-seronegative men and transgender women who have sex with men to oral TDF/FTC or placebo. The iPrEx open-label extension (iPrEx-OLE) study enrolled former PrEP trial participants to receive open-label TDF/FTC.
methodsA cross-sectional analysis compared urine biomarker levels by study arm in iPrEx (N = 100 treatment arm, N = 100 placebo arm). Then, urine biomarker levels were compared before and after PrEP initiation in 109 participants of iPrEx-OLE.
resultsIn iPrEx, there were no significant differences in urine α1m, albuminuria, or proteinuria by treatment arm. In iPrEx-OLE, after 24 weeks on PrEP, urine α1m and proteinuria increased by 21% [95% confidence interval (CI): 10 to 33] and 18% (95% CI: 8 to 28), respectively. The prevalence of detectable α1m increased from 44% to 65% (P < 0.001) and estimated glomerular filtration rate declined by 4 mL/min/1.73 m (P < 0.001). There was no significant change in albuminuria (6%; 95% CI: -7% to 20%).
conclusionPrEP with TDF/FTC was associated with a statistically significant rise in urine α1m and proteinuria after 6 months, suggesting that PrEP may result in subclinical tubule dysfunction.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.