Evidence map›Paper›PMID 25022596›Full record

Trial reportAIDS (London, England)2014

Successful antiretroviral therapy delivery and retention in care among asymptomatic individuals with high CD4+ T-cell counts above 350 cells/μl in rural Uganda.

Vivek Jain, Dathan M Byonanebye, Gideon Amanyire, Dalsone Kwarisiima, Doug Black, Jane Kabami, Gabriel Chamie, Tamara D Clark, James F Rooney, Edwin D Charlebois and 3 more

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in AIDS (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

NCT01479634 nacompletednot on this map

Early Antiretroviral Therapy in Resource Limited Settings in Patients With High CD4+ Cell Counts (EARLI)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2011 to 2015Enrolled279ConditionsHIVArmsStandard ART, Study-Provided ART
NCT01864603 nacompletednot on this map

Sustainable East Africa Research in Community Health

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2021Enrolled150,395ConditionsHIV, Tuberculosis, Hypertension, DiabetesArmsUniversal ART in a streamlined care model, Annual Community Health Campaigns, Targeted PrEP and Targeted testing interventions, Baseline community-based HIV and multi-disease testing
3 · Its place in the literature

Who cites it

26 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

13 authors.

Vivek JainaHIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco (UCSF), California, USA bMakerere University-UCSF (MU-UCSF) Research Collaboration cMakerere University Joint AIDS Program (MJAP), Kampala, Uganda dGilead Sciences, Foster City, California, USA eCenter for AIDS Prevention Studies (CAPS), UCSF, California, USA fDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Dathan M Byonanebye
Gideon Amanyire
Dalsone Kwarisiima
Doug Black
Jane Kabami
Gabriel Chamie
Tamara D Clark
James F Rooney
Edwin D Charlebois
Moses R Kamya
Diane V Havlir
SEARCH Collaboration

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Reducing Failure-to-Initiate ART: Streamlined ART Start Strategy (START)U01AI099959 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2012 to 2016
$39.7M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Clinical and Transtional Science InstituteKL2TR000143 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$11.9M
UCSF HIV Clinical Trials UnitU01AI069502 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HAVLIR, DIANE V · 2007 to 2011
$6.1M
NCATS NIH HHS KL2 TR000143NIAID NIH HHS P30 AI027763NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI099959NIAID NIH HHS UM1 AI069496
6 · The paper itself

Abstract

backgroundHIV antiretroviral therapy (ART) is being rapidly scaled up in sub-Saharan Africa, including recently patients with CD4 T-cell counts above 350 cells/μl. However, concerns persist about adherence and virologic suppression among these asymptomatic, high CD4 cell count individuals.

objectiveTo determine the virologic efficacy and safety of ART among asymptomatic HIV-positive Ugandan adults with high CD4 cell counts above 350 cells/μl via a streamlined model of care.

designProspective nonrandomized clinical study (EARLI Study: clinicaltrials.gov NCT#01479634).

settingPrototypic rural Ugandan HIV clinic. PATIENTS/

participantsAsymptomatic, ART-naive adults (aged >18 years, N = 197) with CD4 at least 350 cells/μl, without pregnancy or WHO stage 3/4 illness.

interventionsART included tenofovir/emtricitabine/efavirenz, with ritonavir/lopinavir substitution for efavirenz available. Streamlined ART model included nurse-driven visits with physician back-up, basic safety laboratory monitoring with HIV viral load, clinician telephone contact, and defaulter tracking. No incentives were provided. OUTCOMES: Undetectable viral load (≤400 copies/ml) at 24 and 48 weeks [intention to treat (ITT); missing = detectable), self-reported ART adherence, retention in care, and laboratory/clinical ART toxicities.

resultsOf the 197 patients with CD4 above 350 cells/μl, median CD4 cell count was 569 cells/μl (interquartile range 451-716). Undetectable viral load was achieved in 189 of 197 (95.9%, ITT) and 189 of 195 (96.9%, ITT) of participants at weeks 24 and 48, respectively. Self-reported adherence was 98% and 192 of 197 (97%) of the patients were retained at week 48. Laboratory adverse events and hospitalizations were rare.

conclusionsWe demonstrate high virologic suppression, retention, and safety among asymptomatic individuals with CD4 above 350 cells/μl in a prototypic Ugandan clinic. Our results challenge current concerns that individuals with high CD4 cell count lack motivation for ART, and may not achieve sustained virologic suppression.

Indexed as

Drug MonitoringAdultAnti-Retroviral AgentsAsymptomatic DiseasesCD4 Lymphocyte CountDrug-Related Side Effects and Adverse ReactionsFemaleHIV InfectionsHumansMalePregnancyProspective StudiesRural PopulationTreatment OutcomeUgandaViral LoadAnti-Retroviral Agents

Identifiers

PMID25022596
PMCPMC4894849

What OpenQuestion holds

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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.