HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand

To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women. This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand. Each woman (CD4 cell count 51-500 cells/microl and not on antiretroviral therapy)...

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Published in:	AIDS (London) Vol. 24; no. 5; pp. 717 - 722
Main Authors:	MCLEAN, Catherine A, VAN DE WIJGERT, Janneke H. H. M, MARKOWITZ, Lauri E, KILMARX, Peter H, JONES, Heidi E, KARON, John M, MCNICOLL, Janet M, WHITEHEAD, Sara J, BRAUNSTEIN, Sarah, ACHALAPONG, Jullapong, CHAIKUMMAO, Supaporn, TAPPERO, Jordan W
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD Lippincott Williams & Wilkins 13-03-2010
Subjects:	Acquired immune deficiency syndrome Administration, Intravaginal Adult Age AIDS/HIV Anti-Infective Agents, Local - therapeutic use antiretroviral agents antiretroviral therapy Biological and medical sciences Carrageenan - therapeutic use CD4 antigen CD4 Lymphocyte Count Cell number Cross-Over Studies Drugs Epidemiology. Vaccinations Epithelial cells Female Females flora Gels General aspects Genital microflora Hemoglobin HIV Infections - drug therapy HIV Infections - transmission HIV Infections - virology HIV-1 - drug effects HIV-1 - physiology Human immunodeficiency virus Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Leukocytes Lymphocytes Medical sciences RNA RNA, Viral safety engineering Sexual Behavior Thailand Treatment Outcome Vagina Vaginal Creams, Foams, and Jellies - therapeutic use Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral Load Virus Shedding Thailand Asia Human Immunopathology Genital system Retroviridae Vagina AIDS virus shedding Thailand Immune deficiency Lentivirus Antimicrobial agent Infection Virus Prevention Sexually transmitted disease HIV Viral disease prevention of sexual transmission Clinical trial Female clinical trials vaginal microbicides Human immunodeficiency virus Woman
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Summary:	To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women. This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand. Each woman (CD4 cell count 51-500 cells/microl and not on antiretroviral therapy) used each treatment (Carraguard, methylcellulose placebo, and no-product) once daily for 7 days during each 1-month period (3-week wash-out). Women were randomized to one of the six possible treatment sequences. Safety assessments were conducted at baseline (pregel), 15 min postgel, day 7, and day 14, and included HIV RNA measurements in cervicovaginal lavage (CVL) specimens. Sixty women were enrolled, and 99% of scheduled study visits were completed. At baseline, median age (34 years), CD4 lymphocyte count (296 cells/microl), plasma HIV viral load (4.6 log10 copies/ml), CVL HIV viral load (3.1 log10 total copies per CVL), and sexual behaviors were similar among randomization groups. HIV viral load, leukocyte and hemoglobin levels, and epithelial cell counts in CVLs were lower 15 min after application of Carraguard or placebo compared with no product; CVL HIV viral load was still lower at day 7 but returned to baseline by day 14. Carraguard use was not associated with prevalent or incident genital findings or abnormal vaginal flora. Carraguard appears to be well tolerated for once-daily vaginal use by HIV-infected women. The observed reduction in CVL HIV viral load in the gel months may be clinically relevant but could have resulted from interference with sample collection by study gels.
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ISSN:	0269-9370 1473-5571
DOI:	10.1097/QAD.0b013e328333bf89