Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016
Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 56 citations in OpenAlex.
- The safety and tolerability of oral TDF/FTC as pre-exposure prophylaxis among men who have sex with men in China: a prospective cohort study.BMC infectious diseases · 2026Trial
- Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine reduced Streptococcus and increased Erysipelotrichaceae in rectal microbiota.Scientific reports · 2018Trial
- Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial.AIDS and behavior · 2018Trial
- In Vitro Pharmacokinetic Properties of MK-2048, a Potent Drug Candidate for HIV Prevention.Viruses · 2026Article
- Intensive longitudinal follow-up of cisgender and transgender women engaged in sex work during the three months following initiation of daily oral PrEP: A series of case-studies with mixed-method assessments.PLOS global public health · 2026Article
- Statistical Methods for Binary Outcomes Adjusting for Outcome Dependent Sampling in Longitudinal Studies with Nonignorable Dropout.bioRxiv : the preprint server for biology · 2025Article
- Sum of the parts: a cascade of adverse effects.Australian prescriber · 2024Article
- Social, economic, and physical side effects impact PrEP uptake and persistence among transgender women in Peru.BMC public health · 2024Article
- Restarting pre-exposure prophylaxis (PrEP) for HIV: a systematic review and meta-analysis.EClinicalMedicine · 2024Article
- Strategies to Close the PrEP Uptake Gap Among Transgender People and Men Who Have Sex with Men in Tshwane, South Africa: Perspectives from the Community.AIDS and behavior · 2024Article
- Pre-Exposure Prophylaxis and HIV Prevention Among Key Populations in Nigeria.International journal of MCH and AIDS · 2024Article
- From training wheels to chemical condoms: Exploring narratives of PrEP discontinuation.Health (London, England : 1997) · 2023Article
- Barriers to Pre-Exposure Prophylaxis (PrEP) use for HIV: an integrative review.Revista brasileira de enfermagem · 2023Review
- PrEP uptake and persistence amongst HIV-negative women who exchange sex for money or commodities in Kampala, Uganda: A qualitative inquiry assessing the influence of pregnancy.PLOS global public health · 2023Article
- Oral conditions and salivary analysis in HIV-uninfected subjects using preexposure prophylaxis.Medicina oral, patologia oral y cirugia bucal · 2022Article
- Association of HIV Preexposure Prophylaxis Use With HIV Incidence Among Men Who Have Sex With Men in China: A Nonrandomized Controlled Trial.JAMA network open · 2022Article
- The relevance of pre-exposure prophylaxis in gay men's lives and their motivations to use it: a qualitative study.BMC public health · 2021Article
- Impact of long-term antiretroviral therapy on gut and oral microbiotas in HIV-1-infected patients.Scientific reports · 2021Article
- The demographic features and outcome indicators of the Barbados HIV Pre-exposure Prophylaxis Program, 2018-2019.Revista panamericana de salud publica = Pan American journal of public health · 2021Article
- Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.Current HIV/AIDS reports · 2020Review
Corrections and comments
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Authors and funding
13 authors at 12 institutions in 3 countries.
Funding
Abstract
backgroundBlinded clinical trials have reported a modest and transient "start-up syndrome" with initiation of tenofovir-based pre-exposure prophylaxis (PrEP). We evaluate this phenomenon and its effect on adherence in an open-label PrEP study.
methodsIn the iPrEx open-label extension (OLE) study, an 18-month open-label, multi-site PrEP cohort taking daily oral co-formulated tenofovir/emtricitabine, we examined the prevalence and duration of PrEP-associated symptoms and their effect on adherence, assessed by drug levels in dried blood spots tested monthly for the first 3 months.
resultsSymptom reports peaked within the first month, with 39% reporting potentially PrEP-related symptoms compared to 22% at baseline. Symptoms largely resolved to pre-PrEP levels by 3 months.Symptoms varied substantially in frequency by study site (range in 1-month symptoms: 11% to 70%). Nongastrointestinal (GI) symptoms were not associated with adherence (odds ratio [OR] = 1.2, 95% confidence interval [CI], .4-3.7); however, GI-associated symptoms in the first 4 weeks were inversely associated with adherence at 4 weeks (OR = 0.47, 95% CI, .23-.96). Reports of GI symptoms were associated with 7% (95% CI, 4%-11%) of suboptimal adherence in this cohort.
conclusionsPrEP-associated symptoms in the open-label setting occur in a minority of users and largely resolve within 3 months. GI symptoms are associated with a modest reduction in PrEP adherence, but good adherence is possible even in the presence of frequent symptom reports. CLINICAL TRIALS REGISTRATION: Clinicaltrials.govNCT00458393.
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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.