Safety and acceptability of the candidate microbicide Carraguard in Thai Women: findings from a Phase II Clinical Trial.
OBJECTIVE
To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel.


METHODS
A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand.


METHODS
Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews.


RESULTS
One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability.


CONCLUSIONS
Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.
Kilmarx
Peter H
PH
Thai Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand. pbk4@cdc.gov
van de Wijgert
Janneke H H M
JH
Chaikummao
Supaporn
S
Jones
Heidi E
HE
Limpakarnjanarat
Khanchit
K
Friedland
Barbara A
BA
Karon
John M
JM
Manopaiboon
Chomnad
C
Srivirojana
Nucharee
N
Yanpaisarn
Somboonsak
S
Supawitkul
Somsak
S
Young
Nancy L
NL
Mock
Philip A
PA
Blanchard
Kelly
K
Mastro
Timothy D
TD
D000282:Administration, Intravaginal; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D016503:Drug Delivery Systems; D005260:Female; D005782:Gels; D006801:Humans; D008747:Methylcellulose; D010342:Patient Acceptance of Health Care; D010919:Placebos; D012449:Safety; D012725:Sexual Behavior; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D013785:Thailand; D014623:Vaginal Diseases / Q000188:drug therapy*
D000890:Anti-Infective Agents; D005782:Gels; D010919:Placebos; D008747:Methylcellulose