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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01192282
Enrollment
156
Registered
2010-09-01
Start date
2010-04-30
Completion date
2012-08-31
Last updated
2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Warts, Human Papilloma Virus

Keywords

Female Genital Warts, HPV Typing, HIV Status, Treatment Modalities and Recurrence, Socio-economic Burdens

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 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.

Interventions

PROCEDUREMedical / 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.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University of Cape Town
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HPV DNA and HIV Status18 MonthsHPV DNA Positivity and HIV Status
HPV DNA and Pap Smear Results18 MonthsRelationship between HPV DNA Positivity and Pap Smear Results
Number of HPV Genotypes Isolated by HIV StatusUp to 18 monthsNumber of HPV Genotypes isolated according to HIV Status
Commonest HPV Genotypes Isolated by HIV Status18 months10 commonest types of HPV isolated according to HIV status

Countries

South Africa

Participant flow

Recruitment details

All female patients with genital warts referred to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town, South Africa between 1st April 2010 and 30 September 2010. Those who were pregnant or too frail or ill for a gynaecological examination were excluded.

Pre-assignment details

No Applicable.

Participants by arm

ArmCount
New Cases
Newly diagnosed cases of genital warts
94
Recurrent Cases
Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
40
Persistent Cases
The warts presence after completion of treatment
22
Total156

Baseline characteristics

CharacteristicNew CasesTotalPersistent CasesRecurrent Cases
Age at First Sexual Intercourse
14 or Less (Years)
9 Participants12 Participants1 Participants2 Participants
Age at First Sexual Intercourse
15 - 19 (Years)
69 Participants116 Participants14 Participants33 Participants
Age at First Sexual Intercourse
20 and Above (Years)
16 Participants27 Participants6 Participants5 Participants
Age at First Sexual Intercourse
Virgo Intacta (Years)
0 Participants1 Participants1 Participants0 Participants
Age, Customized28.64 Years29.21 Years29.91 Years30.18 Years
Education Level
Primary
13 Participants16 Participants3 Participants0 Participants
Education Level
Secondary
67 Participants116 Participants13 Participants36 Participants
Education Level
Tertiary
14 Participants24 Participants6 Participants4 Participants
HIV Status
Negative
21 Participants29 Participants5 Participants3 Participants
HIV Status
Positive
71 Participants123 Participants16 Participants36 Participants
HIV Status
Unknown
2 Participants4 Participants1 Participants1 Participants
Marital Status
Married
13 Participants21 Participants4 Participants4 Participants
Marital Status
Separated / Divorced / Widow
6 Participants13 Participants4 Participants3 Participants
Marital Status
Single, Not Sexually Active
19 Participants30 Participants5 Participants6 Participants
Marital Status
Single, Sexually Active
56 Participants92 Participants9 Participants27 Participants
Sex: Female, Male
Female
94 Participants156 Participants22 Participants40 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Smoking
No
77 Participants126 Participants15 Participants34 Participants
Smoking
Previously
8 Participants14 Participants3 Participants3 Participants
Smoking
Yes
9 Participants16 Participants4 Participants3 Participants
Treatment Modalities
Electrocautery / Laser Ablation under GA
17 Participants33 Participants7 Participants9 Participants
Treatment Modalities
Electrocautery under LA
68 Participants109 Participants13 Participants28 Participants
Treatment Modalities
Local Ablation with Tricholoroacetic Acid (TCA)
7 Participants11 Participants2 Participants2 Participants
Treatment Modalities
TCA + Electrocautery
2 Participants3 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
28 / 1235 / 290 / 4
serious
Total, serious adverse events
0 / 1230 / 290 / 4

Outcome results

Primary

Commonest HPV Genotypes Isolated by HIV Status

10 commonest types of HPV isolated according to HIV status

Time frame: 18 months

ArmMeasureGroupValue (NUMBER)
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 1146 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 633 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 8919 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 6116 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 5512 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 6212 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 819 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 168 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 188 Participants
HIV PositiveCommonest HPV Genotypes Isolated by HIV StatusHPV 458 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 160 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 1110 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 620 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 69 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 450 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 890 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 810 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 610 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 180 Participants
HIV NegativeCommonest HPV Genotypes Isolated by HIV StatusHPV 550 Participants
Primary

HPV DNA and HIV Status

HPV DNA Positivity and HIV Status

Time frame: 18 Months

Population: Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.

ArmMeasureGroupValue (NUMBER)
HIV PositiveHPV DNA and HIV StatusHPV Positive96 participants
HIV PositiveHPV DNA and HIV StatusHPV Negative5 participants
HIV NegativeHPV DNA and HIV StatusHPV Positive19 participants
HIV NegativeHPV DNA and HIV StatusHPV Negative2 participants
HIV UnknownHPV DNA and HIV StatusHPV Positive4 participants
HIV UnknownHPV DNA and HIV StatusHPV Negative0 participants
Primary

HPV DNA and Pap Smear Results

Relationship between HPV DNA Positivity and Pap Smear Results

Time frame: 18 Months

Population: Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.

ArmMeasureGroupValue (NUMBER)
HIV PositiveHPV DNA and Pap Smear ResultsNormal42 Participants
HIV PositiveHPV DNA and Pap Smear ResultsLow Grade Squamous Intraepithelial Lesion59 Participants
HIV PositiveHPV DNA and Pap Smear ResultsHigh Grade Squamous Intraepithelial Lesion10 Participants
HIV PositiveHPV DNA and Pap Smear ResultsAtypical Squamous Cell of Undetermined Significanc6 Participants
HIV NegativeHPV DNA and Pap Smear ResultsAtypical Squamous Cell of Undetermined Significanc0 Participants
HIV NegativeHPV DNA and Pap Smear ResultsNormal5 Participants
HIV NegativeHPV DNA and Pap Smear ResultsHigh Grade Squamous Intraepithelial Lesion0 Participants
HIV NegativeHPV DNA and Pap Smear ResultsLow Grade Squamous Intraepithelial Lesion2 Participants
Primary

Number of HPV Genotypes Isolated by HIV Status

Number of HPV Genotypes isolated according to HIV Status

Time frame: Up to 18 months

Population: 119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.

ArmMeasureGroupValue (NUMBER)
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status2 HPV Genotype12 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status5 HPV Genotype5 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status4 HPV Genotype4 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status15 HPV Genotype1 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status6 HPV Genotype3 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status1 HPV Genotype44 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status11 HPV Genotype2 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status7 HPV Genotype5 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV StatusNo Genotype Isolated but B-Globin Positive9 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status3 HPV Genotype9 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status8 HPV Genotype1 participants
HIV PositiveNumber of HPV Genotypes Isolated by HIV Status9 HPV Genotype1 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status8 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status9 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status11 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status15 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status4 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV StatusNo Genotype Isolated but B-Globin Positive2 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status5 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status2 HPV Genotype1 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status6 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status1 HPV Genotype14 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status7 HPV Genotype0 participants
HIV NegativeNumber of HPV Genotypes Isolated by HIV Status3 HPV Genotype2 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status6 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status1 HPV Genotype1 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status2 HPV Genotype2 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status3 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status4 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status5 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV StatusNo Genotype Isolated but B-Globin Positive1 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status7 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status8 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status9 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status11 HPV Genotype0 participants
HIV UnknownNumber of HPV Genotypes Isolated by HIV Status15 HPV Genotype0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026