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

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 wome...

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Bibliographic Details
Published in:	Journal of acquired immune deficiency syndromes (1999) Vol. 46; no. 5; pp. 538 - 546
Main Authors:	VAN DE WIJGERT, Janneke H. H. M, BRAUNSTEIN, Sarah L, FRIEDLAND, Barbara A, HART, Clyde E, RAMJEE, Gita, MORAR, Neetha S, JONES, Heidi E, MADURAI, Lorna, EVANS STRICKFADEN, Tammy T, MOODLEY, Manivasan, ABOOBAKER, Jamila, NDLOVU, Gugulethu, FERGUSON, Taja M
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD Lippincott Williams & Wilkins 15-12-2007 Lippincott Williams & Wilkins Ovid Technologies
Subjects:	Adult Anti-Infective Agents, Local - administration & dosage Anti-Infective Agents, Local - adverse effects Biological and medical sciences Birth control Clinical trials Double-Blind Method Female Female Urogenital Diseases - pathology Fundamental and applied biological sciences. Psychology HIV HIV Infections - prevention & control Human immunodeficiency virus Human immunodeficiency virus 1 Human viral diseases Humans Infectious diseases Male Male Urogenital Diseases - pathology Medical sciences Microbiology Middle Aged Miscellaneous Placebos - administration & dosage Reproductive health Reproductive system RNA, Viral - genetics Safety South Africa Vagina - pathology Vagina - virology Vaginal Creams, Foams, and Jellies - administration & dosage Vaginal Creams, Foams, and Jellies - adverse effects Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Virology Virus Shedding South Africa Africa Human Immunopathology Microbiology Toxicity Vagina AIDS virus shedding Immune deficiency Virology Infection Prevention Virus Sexually transmitted disease Viral disease Dissemination prevention of sexual transmission Clinical trial Female South Africa clinical trials vaginal microbicides
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Summary:	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 for 7 to 14 days appeared to be safe in HIV-positive women and men.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1525-4135 1944-7884
DOI:	10.1097/QAI.0b013e318159d5a8