Paper # 1004|
Safety and Acceptability of Silicone Elastomer Vaginal Rings as Potential Microbicide Delivery Method in African Women
Annalene Nel*1, K Young1, J Romano1, C Woodsong1, E Montgomery2, G Masenga3, H Rees4, L-G Bekker5, and S Ganesh6
1Intl Partnership for Microbicides, Silver Spring, MD, US; 2Res Triangle Inst, San Francisco, CA, US; 3Kilimanjaro Christian Med Ctr, Moshi, Tanzania; 4Reproductive Hlth and HIV Res Unit, Johannesburg, South Africa; 5Desmond Tutu HIV Fndn, Cape Town, South Africa; and 6MRC, Durban, South Africa
Background: Vaginal rings are a long-acting dosage
form in development for delivery of HIV microbicides. Rings have been marketed
in the US and Europe since the mid-1990s for menopausal symptoms and since 2002
for contraception; however, African women, a target population for HIV
microbicides, have limited experience with vaginal rings.
Methods: A crossover, safety, and acceptability
study was conducted in healthy, sexually active women at 3 research centers in South Africa and 1 in Tanzania. Women were randomized 1:1 to a placebo vaginal ring for 12 weeks,
followed by a 12-week no treatment observation period, or vice versa. Safety
was assessed by colposcopy, adverse events, and laboratory assessments. Ring
acceptability and adherence were assessed by questionnaires.
Results: Of 169 women, 85% completed the study. Ring
expulsion and removal were reported by 10% and 11% of participants,
respectively. The most common reason for both expulsion and removal was menses
related. In most cases (64%) the ring was washed and re-inserted; 82% of
participants reported no ring removal for the duration of the trial, and 99% of
women reported wearing the ring for at least 80% of the time. Male partner
interviews indicated that men did not feel the ring during intercourse, that it
did not influence their sexual pleasure, and that they did not suffer any side
effects from the rings. Of women, 95% found the ring to be very comfortable.
Vaginal candidiasis was the most common adverse event, occurring in 11% of
women during each period. Vaginal discharge (2%), vaginal odor (2%), and
bacterial vaginitis (2%) were assessed as possibly or probably related to the
ring, and occurred with similar frequency in the observation period. One severe
adverse event of appendicitis was assessed as probably not related to the ring.
At screening, 34% of participants had sexually transmitted infections (STI),
and 12% had STI at the crossover and final study visit; 3 participants (2%)
tested HIV+ during the study, 2 at the crossover visit, and 1 at the
final visit. All questionnaire responders were willing to use the vaginal ring
if shown to be effective for HIV prevention.
Conclusions: The vaginal ring was safe and well
tolerated for 12 weeks in African women. Participant removal of the ring for
menses and cleaning indicates a need for enhanced adherence counseling. All
study participants found the ring acceptable and would use it if shown to
prevent HIV infection.