HIV genital shedding and safety of Carraguard use by HIV-infected women: a crossover trial in Thailand.
OBJECTIVE
To evaluate the safety, including impact on genital HIV RNA shedding, of Carraguard vaginal gel in HIV-infected women.


METHODS
This is a randomized, controlled, crossover study of Carraguard in HIV-infected women in Thailand.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
McLean
Catherine A
CA
Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
van de Wijgert
Janneke Hhm
JH
Jones
Heidi E
HE
Karon
John M
JM
McNicoll
Janet M
JM
Whitehead
Sara J
SJ
Braunstein
Sarah
S
Achalapong
Jullapong
J
Chaikummao
Supaporn
S
Tappero
Jordan W
JW
Markowitz
Lauri E
LE
Kilmarx
Peter H
PH
D000282:Administration, Intravaginal; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002351:Carrageenan / Q000627:therapeutic use*; D018592:Cross-Over Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D012367:RNA, Viral; D012725:Sexual Behavior; D013785:Thailand; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*; D019562:Viral Load; D017201:Virus Shedding
D000891:Anti-Infective Agents, Local; D012367:RNA, Viral; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan