Evidence map›Paper›PMID 24695108›Full record

Trial reportPloS one2014

Incidence and predictors of first line antiretroviral regimen modification in western Kenya.

Seth Inzaule, Juliana Otieno, Joan Kalyango, Lillian Nafisa, Charles Kabugo, Josephine Nalusiba, Daniel Kwaro, Clement Zeh, Charles Karamagi

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04938518 (Investigation of the Impact of Inducible, Replication-competent Latent HIV-1 as an Impediment to HIV/AIDS Cure in the Context of Sustained Viral Suppression), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04938518 unknown statusnot on this mapstarted 2019, after this paper: background citation

Investigation of the Impact of Inducible, Replication-competent Latent HIV-1 as an Impediment to HIV/AIDS Cure in the Context of Sustained Viral Suppression

Typeobservational_patient_registrySponsorKenya Medical Research InstituteRan2019 to 2022Enrolled222ConditionsHIV-1-infection
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Seth InzauleKenya Medical Research Institute, Kisumu, Kenya; Makerere University Medical School, Clinical Epidemiology Unit, Kampala, Uganda.
Juliana OtienoJaramogi Oginga Odinga teaching and Referral Hospital, Kisumu, Kenya.
Joan KalyangoMakerere University Medical School, Clinical Epidemiology Unit, Kampala, Uganda.
Lillian NafisaKenya Medical Research Institute, Kisumu, Kenya.
Charles KabugoMakerere University Medical School, Clinical Epidemiology Unit, Kampala, Uganda.
Josephine NalusibaMakerere University Medical School, Clinical Epidemiology Unit, Kampala, Uganda.
Daniel KwaroKenya Medical Research Institute, Kisumu, Kenya; US Centers for Disease Control and Prevention, HIV-Research Branch, Kisumu, Kenya.
Clement ZehUS Centers for Disease Control and Prevention, HIV-Research Branch, Kisumu, Kenya; Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Charles KaramagiMakerere University Medical School, Clinical Epidemiology Unit, Kampala, Uganda.

Funding

Wellcome TrustWellcome Trust 087540
6 · The paper itself

Abstract

backgroundLimited antiretroviral treatment regimens in resource-limited settings require long-term sustainability of patients on the few available options. We evaluated the incidence and predictors of combined antiretroviral treatment (cART) modifications, in an outpatient cohort of 955 patients who initiated cART between January 2009 and January 2011 in western Kenya.

methodscART modification was defined as either first time single drug substitution or switch. Incidence rates were determined by Poisson regression and risk factor analysis assessed using multivariate Cox regression modeling.

resultsOver a median follow-up period of 10.7 months, 178 (18.7%) patients modified regimens (incidence rate (IR); 18.6 per 100 person years [95% CI: 16.2-21.8]). Toxicity was the most common cited reason (66.3%). In adjusted multivariate Cox piecewise regression model, WHO disease stage III/IV (aHR; 1.82, 95%CI: 1.25-2.66), stavudine (d4T) use (aHR; 2.21 95%CI: 1.49-3.30) and increase in age (aHR; 1.02, 95%CI: 1.0-1.04) were associated with increased risk of treatment modification within the first year post-cART. Zidovudine (AZT) and tenofovir (TDF) use had a reduced risk for modification (aHR; 0.60 95%CI: 0.38-0.96 and aHR; 0.51 95%CI: 0.29-0.91 respectively). Beyond one year of treatment, d4T use (aHR; 2.75, 95% CI: 1.25-6.05), baseline CD4 counts ≤350 cells/mm3 (aHR; 2.45, 95%CI: 1.14-5.26), increase in age (aHR; 1.05 95%CI: 1.02-1.07) and high baseline weight >60kg aHR; 2.69 95% CI: 1.58-4.59) were associated with risk of cART modification.

conclusionsEarly treatment initiation at higher CD4 counts and avoiding d4T use may reduce treatment modification and subsequently improve sustainability of patients on the available limited options.

Indexed as

AdultAge FactorsAnti-Retroviral AgentsCD4 Lymphocyte CountDrug Therapy, CombinationFemaleFollow-Up StudiesHIV InfectionsHumansIncidenceKenyaMaleRetrospective StudiesRisk FactorsAnti-Retroviral Agents

Identifiers

PMID24695108
PMCPMC3973699

What OpenQuestion holds

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LicenceCC BY
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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.