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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192282
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : January 15, 2013
Last Update Posted : January 24, 2013
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Shahila Tayib, University of Cape Town

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.

Condition or disease Intervention/treatment
Genital Warts Human Papilloma Virus Procedure: Medical / Surgical Treatment

Detailed 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.

Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Genital Warts
All female patients with Genital Warts presenting to Groote Schuur Hospital
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.

Primary Outcome Measures :
  1. HPV DNA and HIV Status [ Time Frame: 18 Months ]
    HPV DNA Positivity and HIV Status

  2. HPV DNA and Pap Smear Results [ Time Frame: 18 Months ]
    Relationship between HPV DNA Positivity and Pap Smear Results

  3. Number of HPV Genotypes Isolated by HIV Status [ Time Frame: Up to 18 months ]
    Number of HPV Genotypes isolated according to HIV Status

  4. Commonest HPV Genotypes Isolated by HIV Status [ Time Frame: 18 months ]
    10 commonest types of HPV isolated according to HIV status

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All female patients with Genital Warts presenting to Groote Schuur Hospital, Cape Town

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192282

South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
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

Responsible Party: Shahila Tayib, Dr, University of Cape Town Identifier: NCT01192282     History of Changes
Other Study ID Numbers: 131/2010
First Posted: September 1, 2010    Key Record Dates
Results First Posted: January 15, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Shahila Tayib, University of Cape Town:
Female Genital Warts
HPV Typing
HIV Status
Treatment Modalities and Recurrence
Socio-economic Burdens

Additional relevant MeSH terms:
Condylomata Acuminata
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases