Evidence map›Paper›PMID 20442758›Full record

Trial reportPloS one2010

A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda.

Steven J Reynolds, Cissy Kityo, Claire W Hallahan, Geoffrey Kabuye, Diana Atwiine, Frank Mbamanya, Francis Ssali, Robin Dewar, Marybeth Daucher, Richard T Davey and 4 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

NCT00339456 phase3completednot on this map

A Randomized, Controlled Trial of Short Cycle Intermittent Versus Continuous HAART for the Treatment of Chronic HIV Infection in Uganda

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2002 to 2008Enrolled155ConditionsHIVArmsHAART
NCT04281459 nacompletednot on this mapstarted 2020, after this paper: background citation

Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction

TypeinterventionalSponsorAzienda Ospedaliera Universitaria Integrata VeronaRan2020 to 2020Enrolled33ConditionsHIV-1-infectionArmsHIV Treatment Satisfaction Questionnaire status
NCT04867083 phase3unknown statusnot on this mapstarted 2021, after this paper: background citation

Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2021 to 2024Enrolled440ConditionsHIV InfectionsArmsARV bitherapie
3 · Its place in the literature

Who cites it

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

  1. 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

14 authors.

Steven J ReynoldsNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America. sjr@jhmi.edu
Cissy Kityo
Claire W Hallahan
Geoffrey Kabuye
Diana Atwiine
Frank Mbamanya
Francis Ssali
Robin Dewar
Marybeth Daucher
Richard T Davey
Peter Mugyenyi
Anthony S Fauci
Thomas C Quinn
Mark R Dybul

Funding

Influenza and Emerging Infectious DiseasesZIAAI000984 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DAVEY, RICHARD · 2009 to 2025
$44.1M
International Center for Excellence in Research (ICER) in Uganda: Impact of ARVsZIAAI001040 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REYNOLDS, STEVEN · 2009 to 2025
$23.5M
International Studies of the Acquired Immune Deficiency Syndrome (AIDS)ZIAAI000361 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REDD, ANDREW · 2009 to 2025
$15.8M
Immunologic And Virologic Approaches To HIV-1 TherapeuticsZIAAI000865 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DAVEY, RICHARD · 2009 to 2019
$8.8M
Antiretroviral Treatment Interruption as a Long-term Therapeutic StrategyZIAAI000862 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI REYNOLDS, STEVEN · 2009 to 2010
$57k
Intramural NIH HHS
6 · The paper itself

Abstract

backgroundShort cycle treatment interruption could reduce toxicity and drug costs and contribute to further expansion of antiretroviral therapy (ART) programs.

methodsA 72 week, non-inferiority trial enrolled one hundred forty six HIV positive persons receiving ART (CD4+ cell count > or =125 cells/mm(3) and HIV RNA plasma levels <50 copies/ml) in one of three arms: continuous, 7 days on/7 days off and 5 days on/2 days off treatment. Primary endpoint was ART treatment failure determined by plasma HIV RNA level, CD4+ cell count decrease, death attributed to study participation, or opportunistic infection.

resultsFollowing enrollment of 32 participants, the 7 days on/7 days off arm was closed because of a failure rate of 31%. Six of 52 (11.5%) participants in the 5 days on/2 days off arm failed. Five had virologic failure and one participant had immunologic failure. Eleven of 51 (21.6%) participants in the continuous treatment arm failed. Nine had virologic failure with 1 death (lactic acidosis) and 1 clinical failure (extra-pulmonary TB). The upper 97.5% confidence boundary for the difference between the percent of non-failures in the 5 days on/2 days off arm (88.5% non-failure) compared to continuous treatment (78.4% non failure) was 4.8% which is well within the preset non-inferiority margin of 15%. No significant difference was found in time to failure in the 2 study arms (p = 0.39).

conclusionsShort cycle 5 days on/2 days off intermittent ART was at least as effective as continuous therapy.

trial registrationClinicalTrials.gov NCT00339456.

Indexed as

AdultAnti-Retroviral AgentsCD4 Lymphocyte CountDrug Administration ScheduleFemaleHIV InfectionsHumansMaleMiddle AgedOpportunistic InfectionsRNA, ViralTreatment FailureTreatment OutcomeUgandaViral LoadAnti-Retroviral AgentsRNA, Viral

Identifiers

PMID20442758
PMCPMC2860845

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.