NDLOVU CARE GROUP




















 
From February 2014 to June 2016 Ndlovu Research Centre conducted a HIV prevention clinical trial to determine the safety and efficacy of a vaginal ring, sponsored and led by the International Partnership for Microbicides (IPM).  More than half of all people currently living with HIV are women. In Africa, young women are the group at greatest risk of becoming infected. Despite great advances in preventing and treating HIV, women still face disproportionate risk, and a number of prevention options are not practical or usable by many women. Therefore the goal of The Ring Study was to find a longer-acting and easy-to-use product. Most men don’t feel the Ring during sex, giving women a choice whether to tell their partners that they were using the Ring.

Two Phase III Trials showed that the Dapivirine Monthly Vaginal Ring:
·         is safe and well tolerated when used over time
·         is not associated with increased drug resistance
·         reduced acquisition of HIV-1 infection via vaginal intercourse by 31% (IPM 027) and 27% (MTN 020) in women in sub-Saharan Africa
·         Higher protection seen in women older than 21 years (37% - 56%)
·         HIV-1 protection was greater in subgroups with evidence of better adherence to ring use
·         HIV incidence in placebo arms was as high as 8.2/100PY

These results demonstrate that a vaginal ring providing sustained delivery of an antiretroviral medication can be an important prevention option for women at risk for HIV-1 when used as prescribed. Therefore counseling on the use of this product is essential to establish a reduction in HIV-1 seroconversion.

The Ring Study
DPV
(N = 1300)
Placebo
(N = 650)
DPV vs. Placebo
Number of confirmed seroconversions
77
(5.9%)
56
(8.6%)
-
Total person years of follow-up (years)                
1888
917
-
HIV-1 seroconversion rate (per 100 person-years)
4.08
6.10
HR = 0.69
0.49 to 0.99
% Reduction in HIV-1 seroconversion = 30.67%
(0.90%, 51.50%)
p=0.0401
p-value of log-rank test, stratified for research centre, with H0: HR=1 at two-sided significance level of 0.0466


In June 2016 Ndlovu Research Centre started with the DREAM Study (IPM032), an open-label follow-on trial to IPM027 (The Ring Study) to collect additional safety data and establish adherence to ring use of the dapivirine ring. 

 

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