PMID: 18193495Jan 15, 2008Paper

Carraguard Vaginal Gel Safety in HIV-Positive Women and Men in South Africa

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Janneke H H M van de WijgertGita Ramjee

Abstract

To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men. A randomized, placebo-controlled, triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women; and when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men. In each cohort (n = 20 per cohort), participants were randomized to Carraguard, methylcellulose placebo, or no product (1:1:1). In addition to traditional microbicide trial safety endpoints, the effects of microbicide use on vaginal shedding of HIV-1 RNA and markers of genital inflammation, epithelial sloughing, and microhemorrhage were also explored. Gel compliance was high in both gel-use groups in the 3 cohorts. Carraguard use was not associated with abnormal genital findings, other abnormal clinical findings, markers of genital inflammation, epithelial sloughing or microhemorrhage, or self-reported symptoms in women and men, or with abnormal vaginal flora or genital shedding of HIV-1 RNA in women. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Once-daily use of Carraguard...Continue Reading

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Citations

Feb 24, 2011·Antimicrobial Agents and Chemotherapy·Vanessa PirroneFred C Krebs
Feb 6, 2009·The AAPS Journal·Lisa Cencia Rohan, Alexandra B Sassi
Mar 29, 2011·Antiviral Research·Vanessa PirroneFred C Krebs
Feb 4, 2009·Tropical Medicine & International Health : TM & IH·Natasha L LarkeNicolas Nagot
Mar 18, 2011·Reviews in Medical Virology·Kevin K AriënGuido Vanham
Apr 11, 2015·Advanced Drug Delivery Reviews·Sophia G Antimisiaris, Spyridon Mourtas
Dec 3, 2014·Revista Argentina de microbiología·José A Fernández RomeroGabriela Paglini
Jul 19, 2016·Virology·Kabamba B AlexandreM Khati
Oct 25, 2016·Gynecologic Oncology·Akiva P NovetskyMark H Einstein
Jul 21, 2016·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Barbara A FriedlandGeorge W Creasy
Nov 11, 2008·The Lancet Infectious Diseases·Blayne Cutler, Jessica Justman
Apr 4, 2019·Reviews in Medical Virology·Cui HaoWei Wang
Apr 18, 2009·Current Opinion in HIV and AIDS·Mary PoyntenJohn M Kaldor

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