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

Human Papilloma Virus Clinical Trial

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 Care System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192282
• Other study ID #: 131/2010
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: January 18, 2013
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All female patients with genital warts

Exclusion Criteria:

• Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• Human Papilloma Virus
• Papilloma
• Warts

Intervention

Procedure:
• Medical / Surgical Treatment
All participants received treatment based on the morphology and distributions of lesions. For the treatment with Trichloroacetic Acid (TCA), patients were advised to attend the clinic weekly until no visible lesions seen. For electrosurgery or laser, patients were given a date for admission a day prior to surgery. Post-operatively, she remained in the ward for at least five days.

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV DNA and HIV Status	HPV DNA Positivity and HIV Status	18 Months	No
Primary	HPV DNA and Pap Smear Results	Relationship between HPV DNA Positivity and Pap Smear Results	18 Months	No
Primary	Number of HPV Genotypes Isolated by HIV Status	Number of HPV Genotypes isolated according to HIV Status	Up to 18 months	No
Primary	Commonest HPV Genotypes Isolated by HIV Status	10 commonest types of HPV isolated according to HIV status	18 months	No