Evidence map›Paper›PMID 24562349›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE).

Douglas Shaffer, Michael D Hughes, Fredrick Sawe, Yajing Bao, Agnes Moses, Evelyn Hogg, Shahin Lockman, Judith Currier

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Observational
  7. Observational
  8. Article
  9. Article
  10. Article
  11. 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

8 authors at 5 institutions in 4 countries.

Douglas Shaffer*Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; †U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD; ‡Harvard School of Public Health, Boston, MA; §Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD; ‖University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi; ¶Social & Scientific Systems, Inc., Silver Spring, MD; #Brigham and Women's Hospital, Boston, MA; **Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana; and ††University of California Los Angeles, Los Angeles, CA (Dr. Douglas Shaffer is now with the U.S. Centers for Disease Control and Prevention (CDC), Kigali, Rwanda).
Michael D Hughes
Fredrick Sawe
Yajing Bao
Agnes Moses
Evelyn Hogg
Shahin Lockman
Judith Currier
Harvard University · USKenya Medical Research Institute · KEBrigham and Women's Hospital · USKamuzu Central Hospital · MWSocial and Scientific Systems (United States) · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
United States Military HIV Research Program (MHRP) Clinical Trials UnitUM1AI108568 · NIAID · WALTER REED ARMY INSTITUTE OF RESEARCH · PI Julie A. Ake, Merlin L Robb · 2014 to 2026
$24.3M
Optimizing Antiretroviral Therapy in HIV K24AI056933 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 2003 to 2013
$1.4M
NIAID NIH HHS 5 U01AI069518NIAID NIH HHS AI38838NIAID NIH HHS AI68634NIAID NIH HHS K24 AI056933NIAID NIH HHS K24 AI56933NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069518NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI108568
6 · The paper itself

Abstract

backgroundLimited comparative, prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa.

methodsIn 7 African countries, 741 women with CD4 <200 cells/mm were randomized to tenofovir/emtricitabine (TDF/FTC) plus either nevirapine (NVP, n = 370) or lopinavir/ritonavir (LPV/r, n = 371). Lipids and blood pressure (BP) were evaluated at entry, 48, 96, and 144 weeks. Multivariable linear and logistic regression models were used to evaluate mean risk factor changes and clinically relevant risk factor changes.

resultsAt entry, both NVP and LPV/r groups were similar regarding age [mean = 33.5 (SD = 7.1) years], CD4 [129 (67) cells/mm], and HIV-1 RNA [5.1 (0.6) log10 copies/mL]. Nearly, all women had normal lipids and BP except for high-density lipoprotein (HDL)-cholesterol. Over 144 weeks, the LPV/r compared with NVP group had significantly greater mean lipid increases (eg, non-HDL: +29 vs. +13 mg/dL) and smaller HDL increases (+12 vs. +21 mg/dL). In contrast, the NVP compared with LPV/r group had greater mean increases in BP (eg, diastolic BP: +5 vs. -0.5 mm Hg). Significantly, more women assigned LPV/r had week 144 "abnormal" lipid levels (eg, HDL 29.7% vs. 14.8% and triglycerides 28.6% vs. 8.2%), and significantly, more women assigned NVP had "abnormal" BP (eg, diastolic BP 22.7% vs. 6.5%). Most differences remained significant when adjusted for baseline risk factor, age, CD4, and HIV-1 RNA.

conclusionsIn HIV-infected women initiating antiretroviral therapy in Africa, LPV/r + TDF/FTC was associated with less favorable changes in lipids, and use of NVP + TDF/FTC was associated with less favorable changes in BP.

Indexed as

AdenineAdultAfrica South of the SaharaAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBlood PressureBody Mass IndexCardiovascular DiseasesCD4-Positive T-LymphocytesCholesterol, HDLCholesterol, LDLDeoxycytidineEmtricitabineEndpoint DeterminationFemaleHIV-1AdenineAnti-HIV AgentsCholesterol, HDLCholesterol, LDLDeoxycytidineEmtricitabineLopinavirNevirapineOrganophosphonatesRitonavirRNA, ViralTenofovirTriglycerides

Identifiers

PMID24562349
PMCPMC4109714
OpenAlexW2015442730

What OpenQuestion holds

Textmetadata
LicenceTDM
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.