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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Shahila Tayib, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01192282
First received: August 31, 2010
Last updated: January 18, 2013
Last verified: January 2013

August 31, 2010
January 18, 2013
April 2010
December 2011   (final data collection date for primary outcome measure)
  • HPV DNA and HIV Status [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    HPV DNA Positivity and HIV Status
  • HPV DNA and Pap Smear Results [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Relationship between HPV DNA Positivity and Pap Smear Results
  • Number of HPV Genotypes Isolated by HIV Status [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Number of HPV Genotypes isolated according to HIV Status
  • Commonest HPV Genotypes Isolated by HIV Status [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    10 commonest types of HPV isolated according to HIV status
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Complete list of historical versions of study NCT01192282 on ClinicalTrials.gov Archive Site
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Typing of Human Papilloma Virus (HPV) From Female Genital Warts
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All female patients with Genital Warts presenting to Groote Schuur Hospital, Cape Town

  • Genital Warts
  • Human Papilloma Virus
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.
Genital Warts
All female patients with Genital Warts presenting to Groote Schuur Hospital
Intervention: Procedure: Medical / Surgical Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
August 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01192282
131/2010
No
Shahila Tayib, University of Cape Town
University of Cape Town
Merck Sharp & Dohme Corp.
Principal Investigator: Shahila Tayib, MBChB University of Cape Town
Principal Investigator: Lynette Denny University of Cape Town
University of Cape Town
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP