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
  Purpose

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 Intervention
Genital Warts
Human Papilloma Virus
Procedure: Medical / Surgical Treatment

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • 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


Enrollment: 156
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192282

Locations
South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Shahila Tayib, MBChB University of Cape Town
Principal Investigator: Lynette Denny University of Cape Town
  More Information

No publications provided

Responsible Party: Shahila Tayib, Dr, University of Cape Town
ClinicalTrials.gov Identifier: NCT01192282     History of Changes
Other Study ID Numbers: 131/2010
Study First Received: August 31, 2010
Results First Received: December 15, 2012
Last Updated: January 18, 2013
Health Authority: South Africa: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 15, 2014