A randomised placebo-controlled safety and acceptability trial of PRO 2000 vaginal microbicide gel in sexually active women in Uganda

Anatoli Kamali (1) , Helen Byomire (1) , Catherine Muwonge (1) , Julie Bakobaki (2) , Clare Rutterford (2) , Pius Okong (3) , Albert Profy (4) , Romano Byaruhanga (5) , Stella Namukwaya (1) , Sheena Mccormack (2) , Heiner Grosskurth (1) , Andrew Nunn (2) , Charles J Lacey (6)

1 MRC Uganda
2 MRC Clinical Trials Unit
3 St Francis Hosipital, Kampala
4 Indevus Pharmaceuticals
5 St Francis Hopsital, Kampala
6 University of York [York, UK]

Objectives To determine the safety of 0.5% and 2% PRO 2000 gel in terms of local and systemic adverse events (AEs), and the acceptability of gel use. Design A randomized placebo-controlled trial among healthy, sexually active African women aged 18-45 years. Between June 2003 and September 2004, 180 consenting women were randomized to one of 4 groups: PRO 2000 gel (0.5% or 2%), placebo gel or condom use only. Participants were screened for sexually transmitted infections, with HIV counseling and testing. Women randomised to gel used this intravaginally twice daily for 28 days. Follow-up visits were fortnightly up to 6 weeks from enrolment, and comprised a physical examination including colposcopy, laboratory testing and questionnaire interviews. Results: Ten women were lost to follow-up, none due to AEs. Adherence with total gel doses was 69%. Observed rates of the primary toxicity endpoints, ulceration >2 x 1cm and clinically relevant coagulation abnormalities were, for PRO 2000 0.5%: 1.6% (95% CIs 0.04–8.5%) & 0% (97.5% CIs 0-5.7%), and for PRO 2000 2%: 0% & 0% (97.5% CIs 0-5.9%) Women randomized to active gels did not show an increased rate of AEs. Gel use had no significant effect on haematology and biochemistry results. Women found gel use highly acceptable. Conclusions: Both concentrations of PRO 2000 gel were found to be safe and well tolerated. These data justified testing the gels in large scale effectiveness trials. The final results of these trials are expected by end-2009.

Mots clés: CLINICAL TRIALS; HIV; VAGINAL MICROBICIDES

Anatoli Kamali, Helen Byomire, Catherine Muwonge, Julie Bakobaki, Clare Rutterford, et al.. A randomised placebo-controlled safety and acceptability trial of PRO 2000 vaginal microbicide gel in sexually active women in Uganda. Sexually Transmitted Infections, 2010, 86 (3), pp.222. ⟨10.1136/sti.2009.038372⟩. ⟨hal-00557456⟩