Evidence map›Paper›PMID 25441397›Full record

Trial reportTropical medicine & international health : TM & IH2015

Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial.

Damalie Nakanjako, Isaac Ssinabulya, Rose Nabatanzi, Lois Bayigga, Agnes Kiragga, Moses Joloba, Pontiano Kaleebu, Andrew D Kambugu, Moses R Kamya, Rafick Sekaly and 2 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Tropical medicine & international health : TM & IH, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03037372 (Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
6.3field-weighted citation impact, top 3% of its field
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.

NCT03037372 phase3unknown statusnot on this mapstarted 2017, after this paper: background citation

Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin

TypeinterventionalSponsorMakerere UniversityRan2017 to 2022Enrolled320ConditionsHIV InfectionArmsART, Atorvastatin, ART, Rosuvastatin, ART, No statin, Healthy-HIV-negative
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Adjunct Therapy for CD4Frontiers in immunology · 2021
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. CD8Frontiers in immunology · 2019
    Review
  17. Article
  18. A Low Frequency of IL-17-Producing CD8Frontiers in immunology · 2018
    Article
  19. Article
  20. Article
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

12 authors at 4 institutions in 2 countries.

Damalie NakanjakoDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda; Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda.
Isaac Ssinabulya
Rose Nabatanzi
Lois Bayigga
Agnes Kiragga
Moses Joloba
Pontiano Kaleebu
Andrew D Kambugu
Moses R Kamya
Rafick Sekaly
Alison Elliott
Harriet Mayanja-Kizza
Makerere University · UGUganda Virus Research Institute · UGInfectious Diseases Institute · UGVaccine & Gene Therapy Institute of Florida · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 1988 to 2026
$93.6M
University of California Global Health Institute Program for Fellows and ScholarsR25TW009343 · FIC · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COHEN, CRAIG R, STRATHDEE, STEFFANIE A. · 2012 to 2017
$6.4M
Training of Ugandans in Basic Research on TB and Emerging Infectious DiseasesD43TW009093 · FIC · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · PI ELLNER, JERROLD J. · 2014 to 2023
$2.2M
FIC NIH HHS D43 TW009093FIC NIH HHS R25 TW009343NIAID NIH HHS P30 AI027763Wellcome Trust 084344Wellcome Trust 095778
6 · The paper itself

Abstract

objectiveT-cell activation independently predicts mortality, poor immune recovery and non-AIDS illnesses during combination antiretroviral therapy (cART). Atorvastatin showed anti-immune activation effects among HIV-infected cART-naïve individuals. We investigated whether adjunct atorvastatin therapy reduces T-cell activation among cART-treated adults with suboptimal immune recovery.

methodsA randomised double-blind placebo-controlled crossover trial, of atorvastatin 80 mg daily vs. placebo for 12 weeks, was conducted among individuals with CD4 increase <295 cells/μl after seven years of suppressive cART. Change in T-cell activation (CD3 + CD4 + /CD8 + CD38 + HLADR+) and in T-cell exhaustion (CD3 + CD4 + /CD8 + PD1 + ) was measured using flow cytometry.

resultsThirty patients were randomised, 15 to each arm. Atorvastatin resulted in a 28% greater reduction in CD4 T-cell activation (60% reduction) than placebo (32% reduction); P = 0.001. Atorvastatin also resulted in a 35% greater reduction in CD8-T-cell activation than placebo (49% vs. 14%, P = 0.0009), CD4 T-cell exhaustion (27% vs. 17% in placebo), P = 0.001 and CD8 T-cell exhaustion (27% vs. 16%), P = 0.004. There was no carry-over/period effect. Expected adverse events were comparable in both groups, and no serious adverse events were reported.

conclusionAtorvastatin reduced T-cell immune activation and exhaustion among cART-treated adults in a Ugandan cohort. Atorvastatin adjunct therapy should be explored as a strategy to improve HIV treatment outcomes among people living with HIV in sub-Saharan Africa.

Indexed as

HIV InfectionsAdultAnti-HIV AgentsAtorvastatinCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCohort StudiesCross-Over StudiesDouble-Blind MethodFemaleHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLymphocyte ActivationLymphocyte DepletionAnti-HIV AgentsAtorvastatinHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPyrrolesactivación inmuneactivation immunitaireadjunct therapyantiretroviral therapyatorvastatinatorvastatinaatorvastatineHIV/AIDSimmune activationimmune recoveryreconstitution immunitairerecuperación inmuneterapia adjuntaterapia antirretroviralthérapie antirétroviraletraitement d'appointVIH/SIDA

Identifiers

PMID25441397
PMCPMC4529480
OpenAlexW2007378793

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.