Evidence map›Paper›PMID 21325137›Full record

Trial reportThe Journal of infectious diseases2011

High dose atorvastatin decreases cellular markers of immune activation without affecting HIV-1 RNA levels: results of a double-blind randomized placebo controlled clinical trial.

Anuradha Ganesan, Nancy Crum-Cianflone, Jeanette Higgins, Jing Qin, Catherine Rehm, Julia Metcalf, Carolyn Brandt, Jean Vita, Catherine F Decker, Peter Sklar and 4 more

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

Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01766076 (Use of Atorvastatin as Adjuvant Therapy Among Suboptimal Responders to Antiretroviral Therapy in an African Cohort of HAART-treated Adults), which is not on this map. Cited by 84 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT01766076 phase3completednot on this mapstarted 2013, after this paper: background citation

Use of Atorvastatin as Adjuvant Therapy Among Suboptimal Responders to Antiretroviral Therapy in an African Cohort of HAART-treated Adults: A Randomised Controlled Trial

TypeinterventionalSponsorMakerere UniversityRan2013 to 2014Enrolled30ConditionsAcquired Immune Deficiency Syndrome VirusArmsatorvastatin, Lipitor®, Placebo
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 3 syntheses or guidelines pooled it, 152 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  13. Rosuvastatin preserves renal function and lowers cystatin C in HIV-infected subjects on antiretroviral therapy: the SATURN-HIV trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Trial
  14. Rosuvastatin treatment reduces markers of monocyte activation in HIV-infected subjects on antiretroviral therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Trial
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24 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 1 country.

Anuradha GanesanDivision of Infectious Diseases, National Naval Medical Center, Uniformed Services University, Bethesda, Maryland, USA. anuradha.ganesan@med.navy.mil
Nancy Crum-Cianflone
Jeanette Higgins
Jing Qin
Catherine Rehm
Julia Metcalf
Carolyn Brandt
Jean Vita
Catherine F Decker
Peter Sklar
Mary Bavaro
Sybil Tasker
Dean Follmann
Frank Maldarelli
Naval Medical Center San Diego · USNaval Medical Research Command · USClinical Research Management · USDrexel University · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USPharmaceutical Product Development (United States) · USScience Applications International Corporation (United States) · USWalter Reed National Military Medical Center · US

Funding

Appearance and Disappearance of Drug Resistance MutationsZIABC010820 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MALDARELLI, FRANK · 2009 to 2011
$1.3M
DATA CENTER FOR EPIDEMIOLOGIC INVESTIGATIONS OF HIVN01AI005072 · NIAID · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MCKINLAY, SONJA M · 1990 to 1994
–
NCI NIH HHS N01-CO-12400NIAID NIH HHS Y1-AI-5072
6 · The paper itself

Abstract

background3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitors (statins) exhibit antiviral activity against human immunodeficiency virus type 1 (HIV-1) in vitro and may modulate the immune response to HIV infection. Studies evaluating the antiviral activity of statins have yielded conflicting results.

methodsWe conducted a randomized, double-blind, placebo-controlled crossover trial to investigate the effect of atorvastatin on HIV-1 RNA (primary objective) and cellular markers of immune activation (secondary objective). HIV-infected individuals not receiving antiretroviral therapy were randomized to receive either 8 weeks of atorvastatin (80 mg) or placebo daily. After a 4-6 week washout phase, participants switched treatment assignments. The study had 80% power to detect a 0.3 log(10) decrease in HIV-1 RNA level. Expression of CD38 and HLA-DR on CD4(+) and CD8(+) T cells was used to measure immune activation.

resultsOf 24 randomized participants, 22 completed the study. Although HIV-1 RNA level was unaffected by the intervention (-0.13 log(10) copies/mL; P = .85), atorvastatin use resulted in reductions in circulating proportions of CD4(+) HLA-DR(+) (-2.5%; P = .02), CD8(+) HLA-DR(+) (-5%; P = .006), and CD8(+) HLA-DR(+) CD38(+) T cells (-3%; P = .03). Reductions in immune activation did not correlate with declines in serum levels of low-density lipoprotein cholesterol.

conclusionsShort-term use of atorvastatin was associated with modest but statistically significant reductions in the proportion of activated T lymphocytes.

Indexed as

AdultAtorvastatinCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCross-Over StudiesDouble-Blind MethodHeptanoic AcidsHIV-1HIV InfectionsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMalePlacebosPyrrolesRNA, ViralAtorvastatinHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPlacebosPyrrolesRNA, Viral

Identifiers

PMID21325137
PMCPMC3071124
OpenAlexW2167056324

What OpenQuestion holds

Textmetadata
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.