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Sub-study to an international multi-centre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HPV infection

Project Focus
HPV Prevention and Treatment

Project Location
Soweto and Orange Farm, Johannesburg & Mtubatuba, Kwa Zulu Natal, SA

Duration of Project
2006 – 2009

Project Partners
  • British Medical Research Council Clinical Trials Unit
  • Microbicide Development Programme (MDP)
  • Indevus Pharmaceuticals Inc
  • University of North Carolina

Project Donors

Dr Jocelyn Moyes

Project Aims /Objectives
A randomized, double blind placebo controlled trial to determine the effectiveness of 0.5% and 2% PRO 2000/5 gel in the prevention of incident HPV infection diagnosed by PCR conducted on an endocervical specimen among women at high risk for HPV infection.

Secondary objectives:
  • To determine the efficacy of 0.5% and 2% PRO 2000/5 gel compared to placebo in preventing incident HPV infection by category of type (high risk/low risk/overall positivity), and by individual type.
  • To determine the efficacy of 0.5% and 2% PRO 2000/5 gel compared to placebo in clearing HPV infection.
  • To compare the sensitivity and specificity, and cost of two sampling methods (cervical exfoliated cells collected by a clinician using a brush and cells collected from two self-administered vaginal swabs) for PCR detection of high-risk HPV type.
Project Activities
1,600 women who are participating in the Phase III MDP301 trial and enrolling in Johannesburg and Mtubatuba, South Africa will be recruited and followed up for 52 weeks. Samples will be collected at baseline, at 6 months and at 1 year to look at the prevalence and incidence of HPV in the presence of PRO2000/5; pap smears will be conducted at baseline and 1 year to compare to endocervical swabs as a screening method for early detection of cancer of the cervix.

Anticipated/Actual Results
Establish that PRO 2000/5 could prevent HPV infection and change the natural progression of HPV infection.

Additional Outputs
  • Development of protocol
  • University of Witwatersrand Human Research Ethics Committee approvals
Future Plans
  • To complete enrollment and follow up of study participants
  • Development of a programme of HPV Vaccine preparedness studies

Projects in the STI's & HIV Research Cluster:

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