Clinical Trial: Typing of Human Papilloma Virus (HPV) From Female Genital Warts

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Clinico-Pathological HPV DNA Typing Study of Women With Genital Warts Presenting to Groote Schuur Hospital Over a One Year Period, Evaluated by HIV Status, Psychological Impact and Costs to the Health

Brief Summary: This is a longitudinal observational study of women presenting to Groote Schuur Hospital with genital warts. The study will evaluate the socio-demographic characteristics of the women using a structured questionnaire. It will also document the site and extend of the genital warts and genotyping will be performed on the warts. HIV status will be determined with patient consent, treatment modalities will be documented as will the outcome of treatment over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed as will the costs of treating women with genital warts.

Detailed Summary:

Genital Human Papillomavirus (HPV) infection is the most common sexually transmitted viral disease in the world.1,2 HPV infection on genital epithelia is associated with a range of disease spectra, from visible lesions such as genital warts, cervical, vaginal, vulval, anal and penile intraepithelial cancers and their precursors, or they may co- exist in the latent form in apparently normal epithelium.3,4 It is established that genital warts are associated with low-risk HPV genotypes, with the causative agents being HPV-6 and HPV-11 in almost 100% of cases.5 However, recent studies have shown that 20 to 50% of lesions also contain co-infection with high-risk HPV types.6,7

Although genital warts are not life-threatening, they cause significant psychosocial morbidities resulting in low self-esteem, negative self-perception, embarrassment and anxiety.8,9 Genital warts also represent not only a health problem for the individual, but also an economic burden for society as they carry a high and immediate financial burden and health care cost due to their generally recalcitrant response to conventional therapies.9 With this in mind, immunization with HPV 6/11/16/18 recombinant vaccine holds promise for reducing overall burden on clinical HPV-related diseases.

Genital warts are a common cause for referral to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town which is a tertiary hospital serving the wider Cape Town area and the Western Cape Province. With an increasing number of cases seen requiring multiple clinical visits for treatment and a high number of recurrent and persistent cases, we undertook this study to examine the nature of the disease from a clinical point of view, response to various therapies, the impact of HIV and the types of HPV causing or associated with genital warts in women referred to our clinic.

Sponsor: University of Cape Town

Current Primary Outcome:

• HPV DNA and HIV Status [ Time Frame: 18 Months ]
  HPV DNA Positivity and HIV Status
• HPV DNA and Pap Smear Results [ Time Frame: 18 Months ]
  Relationship between HPV DNA Positivity and Pap Smear Results
• Number of HPV Genotypes Isolated by HIV Status [ Time Frame: Up to 18 months ]
  Number of HPV Genotypes isolated according to HIV Status
• Commonest HPV Genotypes Isolated by HIV Status [ Time Frame: 18 months ]
  10 commonest types of HPV isolated according to HIV status

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Cape Town

Dates:
Date Received: August 31, 2010
Date Started: April 2010
Date Completion:
Last Updated: January 18, 2013
Last Verified: January 2013