Evidence map›Paper›PMID 22701683›Full record

Trial reportPloS one2012

Effects of valacyclovir on markers of disease progression in postpartum women co-infected with HIV-1 and herpes simplex virus-2.

Alison C Roxby, Alison L Drake, Francisca Ongecha-Owuor, James N Kiarie, Barbra Richardson, Daniel N Matemo, Julie Overbaugh, Sandra Emery, Grace C John-Stewart, Anna Wald and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Valacyclovir Decreases Plasma HIV-1 RNA in HSV-2 Seronegative Individuals: A Randomized Placebo-Controlled Crossover Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Trial
  4. Trial
  5. Article
  6. Review
  7. Review
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

11 authors at 4 institutions in 2 countries.

Alison C RoxbyDepartment of Medicine, University of Washington, Seattle, Washington, United States of America. aroxby@u.washington.edu
Alison L Drake
Francisca Ongecha-Owuor
James N Kiarie
Barbra Richardson
Daniel N Matemo
Julie Overbaugh
Sandra Emery
Grace C John-Stewart
Anna Wald
Carey Farquhar
University of Washington · USFred Hutch Cancer Center · USUniversity of Nairobi · KEKenyatta University · KE

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
THE PERINATAL COMPLICATIONS OF ASYMPTOMATIC GENITAL HERPES SIMPLEX VIRUSP01AI030731 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 1991 to 2017
$34.3M
Fogarty International Clinical Research Scholars Support Center @ Vanderbilt-AAMCR24TW007988 · FIC · VANDERBILT UNIVERSITY · PI VERMUND, STEN H. · 2007 to 2011
$27.6M
VENEREAL DISEASET32AI007140 · NIAID · UNIVERSITY OF WASHINGTON · PI Julia Cook Dombrowski · 1985 to 2026
$19.4M
INTERNATIONAL TRAINING GRANT IN EPIDEMIOLOGYD43TW000007 · FIC · UNIVERSITY OF WASHINGTON · PI FARQUHAR, CAREY · 1988 to 2012
$16.3M
THE ROLE OF ANTIBODIES IN MOTHER TO CHILD HIV TRANSMISSIONR01AI076105 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI OVERBAUGH, JULIE M. · 2008 to 2023
$8.8M
Clinical Research in HSV InfectionsK24AI071113 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 2006 to 2015
$1.7M
HIV-1 and Protective Immunity against Common Childhood PathogensK24AI087399 · NIAID · UNIVERSITY OF WASHINGTON · PI FARQUHAR, CAREY · 2010 to 2014
$647k
HSV-2 suppression to reduce maternal plasma, genital and breast milk HIV-1 levelsR03HD057773 · NICHD · UNIVERSITY OF WASHINGTON · PI FARQUHAR, CAREY · 2008 to 2009
$203k
FIC NIH HHS D43 TW000007FIC NIH HHS D43-TW000007FIC NIH HHS R24 TW007988NIAID NIH HHS K24 AI071113NIAID NIH HHS K24 AI087399NIAID NIH HHS P01 AI030731NIAID NIH HHS P01 AI30731NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI076105NIAID NIH HHS T32 AI007140NIAID NIH HHS T32AI07140-32NICHD NIH HHS R03 HD 057773NICHD NIH HHS R03 HD057773NICHD NIH HHS R03 HD 057773-02S1
6 · The paper itself

Abstract

objectiveHerpes simplex virus type 2 (HSV-2) suppression has been shown to reduce HIV-1 disease progression in non-pregnant women and men, but effects on pregnant and postpartum women have not been described.

methodsWe analyzed data from a cohort of Kenyan women participating in a randomized clinical trial of HSV-2 suppression. Pregnant HIV-1-seropositive, HSV-2-seropositive women who were not eligible for antiretroviral therapy (WHO stage 1-2, CD4>250 cells/µl) were randomized to either 500 mg valacyclovir or placebo twice daily from 34 weeks gestation through 12 months postpartum. Women received zidovudine and single-dose nevirapine for prevention of mother-to-child HIV-1 transmission. HIV-1 progression markers, including CD4 count and plasma HIV-1 RNA levels, were measured serially. Multivariate linear regression was used to compare progression markers between study arms.

resultsOf 148 women randomized, 136 (92%) completed 12 months of postpartum follow-up. While adjusted mean CD4 count at 12 months (565 cells/µl placebo arm, 638 cells/µl valacyclovir arm) increased from antenatal levels in both arms, the mean CD4 count increase was 73 cells/µl higher in the valacyclovir arm than placebo arm (p = 0.03). Mean increase in CD4 count was 154 cells/µl in the valacyclovir arm, almost double the increase of 78 cells/µl in the placebo arm. At 12 months, adjusted HIV-1 RNA levels in the placebo arm increased by 0.66 log(10) copies/ml from baseline, and increased by only 0.21 log(10) copies/ml in the valacyclovir arm (0.40 log(10) copies/ml difference, p = 0.001).

conclusionWomen randomized to valacyclovir suppressive therapy during pregnancy and postpartum had greater increases in CD4 counts and smaller increases in plasma HIV-1 RNA levels than women in the placebo arm. Valacyclovir suppression during pregnancy and breastfeeding may improve outcomes and delay antiretroviral therapy for HIV-1/HSV-2 co-infected women.

Indexed as

Herpesvirus 2, HumanHIV-1AcyclovirAntiviral AgentsBiomarkersCD4 AntigensDisease ProgressionFemaleHerpes GenitalisHIV InfectionsHumansKenyaLinear ModelsNevirapinePostpartum PeriodPregnancyAcyclovirAntiviral AgentsBiomarkersCD4 AntigensNevirapineRNA, ViralValacyclovirValineZidovudine

Identifiers

PMID22701683
PMCPMC3373516
OpenAlexW2079934697

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.