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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
No increase in cervicovaginal proinflammatory cytokines after Carraguard use in a placebo-controlled randomized clinical trial
Journal of Acquired Immune Deficiency Syndromes, Volume 47, No. 2, Year 2008
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Description
BACKGROUND: Assessment of cervicovaginal cytokine levels may be helpful to evaluate subclinical epithelial inflammation during safety evaluations of candidate microbicides. METHODS: Fifty-five HIV-seronegative Thai women were enrolled in a safety trial of the candidate microbicide Carraguard and were randomized to use Carraguard or placebo gel before vaginal sex. Cervicovaginal lavages were collected at baseline and after 1 month of gel use; levels of interleukin (IL)-1β, IL-6, IL-8, and secretory leukocyte protease inhibitor (SLPI) were measured using microwell plate-based enzyme immunoassays. Median levels were compared between the baseline and 1-month follow-up visits using paired t tests; the median change between groups was compared using Wilcoxon rank sum tests. Women were examined for the presence of genital findings; the association between genital findings and cytokine levels was studied. RESULTS: No increase in levels of proinflammatory cytokines after use of Carraguard gel or placebo gel was observed during the study. The median change from the baseline to 1 month of follow-up was not significantly different between Carraguard and placebo groups (IL-1β: -0.3 pg/mL vs. -3.93 pg/mL; P = 0.4, IL-6: -0.3 pg/mL vs. 0 pg/mL; P = 0.3, IL-8: -40.1 pg/mL vs. -53.2 pg/mL; P = 0.8, and SLPI: -26.5 pg/mL vs. 12.6 pg/mL; P = 0.07). Genital findings with intact epithelium were found in 16 (29%) women; these women tended to have somewhat higher IL-6 levels than those with normal epithelium (14.9 pg/mL vs. 8.8 pg/mL; P = 0.08). CONCLUSION: We found no increase in proinflammatory cytokines after Carraguard and placebo gel use, suggesting that neither gel causes inflammation. Further studies to assess the role of cytokines in microbicide safety studies are warranted. © 2008 Lippincott Williams & Wilkins, Inc.
Authors & Co-Authors
Bollen, Liesbeth J.M.
Thailand, Bangkok
Centers for Disease Control Cdc, Thailand Field Station
Thailand, Nontaburi
Thailand Ministry of Public Health
Blanchard, Kelly
United States, New York
The Population Council, Inc.
Kilmarx, Peter H.
United States, Atlanta
Centers for Disease Control and Prevention
Chaikummao, Supaporn
Thailand, Bangkok
Centers for Disease Control Cdc, Thailand Field Station
Connolly, Catherine Anne
South Africa, Tygerberg
South African Medical Research Council
Wasinrapee, Punneporn
Thailand, Bangkok
Centers for Disease Control Cdc, Thailand Field Station
Srivirojana, Nucharee
United States, New York
The Population Council, Inc.
Achalapong, Jullapong
Thailand, Chiang Rai
Chiang Rai Prachanukhro Hospital
Tappero, Jordan W.
Thailand, Bangkok
Centers for Disease Control Cdc, Thailand Field Station
United States, New York
The Population Council, Inc.
McNicholl, Janet M.
Thailand, Bangkok
Centers for Disease Control Cdc, Thailand Field Station
United States, New York
The Population Council, Inc.
Statistics
Citations: 47
Authors: 10
Affiliations: 6
Identifiers
Doi:
10.1097/QAI.0b013e31815d2f12
ISSN:
15254135
Research Areas
Infectious Diseases
Sexual And Reproductive Health
Study Design
Randomised Control Trial
Cohort Study
Participants Gender
Female