Genital WartsNCT01192282

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

An observational study of Genital Warts and Human Papilloma Virus, run by University of Cape Town at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Genital Warts, Human Papilloma Virus
What is being tested?: Medical / Surgical Treatment
Type of treatment: Surgery or procedure
How many people: 156 participants
Where: 1 siteSouth Africa
Study dates: Apr 2010to Aug 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

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

Who may be able to join

All female patients with genital warts

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Groote Schuur Hospital
Cape Town, Western Cape, 7925

Other trials in South Africa

About this study

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

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.

Read the 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.

Conditions: Genital Warts, Human Papilloma Virus
Being tested: Medical / Surgical Treatment
Keywords: Female Genital Warts, HPV Typing, HIV Status, Treatment Modalities and Recurrence, Socio-economic Burdens
Medical subject headings: Condylomata Acuminata, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical / Surgical TreatmentProcedure or surgery
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.

Study groups in NCT01192282
Study group	Role	What they receive
Genital Warts		All female patients with Genital Warts presenting to Groote Schuur Hospital Receives: Procedure: Medical / Surgical Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

HPV DNA and HIV Status
HPV DNA Positivity and HIV Status
Measured: 18 Months
HPV DNA and Pap Smear Results
Relationship between HPV DNA Positivity and Pap Smear Results
Measured: 18 Months
Number of HPV Genotypes Isolated by HIV Status
Number of HPV Genotypes isolated according to HIV Status
Measured: Up to 18 months
Commonest HPV Genotypes Isolated by HIV Status
10 commonest types of HPV isolated according to HIV status
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Aug 2012

First posted1 Sep 2010 (estimated)
Study startApr 2010
Primary completionDec 2011
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Genital WartsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01192282
Sponsor's protocol ID: 131/2010
Status last verified: Jan 2013
First submitted: 31 Aug 2010
Last updated: 24 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts

All Genital Warts trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01192282
Acronym / sponsor ID: 131/2010
Conditions: Genital Warts, Human Papilloma Virus
Keywords: Female Genital Warts, HPV Typing, HIV Status, Treatment Modalities and Recurrence, Socio-economic Burdens
Study type: Observational
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: University of Cape TownUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Apr 2010
Primary completion: Dec 2011 (actual)
Study completion: Aug 2012 (actual)
First posted: 1 Sep 2010 (estimated)
Results: Posted 15 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Genital Warts	–	Procedure: Medical / Surgical TreatmentAll female patients with Genital Warts presenting to Groote Schuur Hospital

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: All female patients with Genital Warts presenting to Groote Schuur Hospital, Cape Town

Key inclusion criteria (1 listed)

All female patients with genital warts

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medical / Surgical TreatmentAll 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.	Procedure or surgery	Genital Warts

Primary outcome

HPV DNA and HIV Status
Time frame: 18 Months
HPV DNA Positivity and HIV Status
HPV DNA and Pap Smear Results
Time frame: 18 Months
Relationship between HPV DNA Positivity and Pap Smear Results
Number of HPV Genotypes Isolated by HIV Status
Time frame: Up to 18 months
Number of HPV Genotypes isolated according to HIV Status
Commonest HPV Genotypes Isolated by HIV Status
Time frame: 18 months
10 commonest types of HPV isolated according to HIV status

Results and safety

Results posted to the registry on 15 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Number of Participants	156	156

Primary outcome: HPV DNA and HIV Status

Time frame: 18 Months. Number. Unit: participants

Measure	HIV Positive n = 101	HIV Negative n = 21	HIV Unknown n = 4
HPV Positive	96	19	4
HPV Negative	5	2	0

Population analysed: 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.

Primary outcome: HPV DNA and Pap Smear Results

Time frame: 18 Months. Number. Unit: Participants

Measure	HPV DNA Positive n = 118	HPV DNA Negative n = 7
Normal	42	5
Low Grade Squamous Intraepithelial Lesion	59	2
High Grade Squamous Intraepithelial Lesion	10	0
Atypical Squamous Cell of Undetermined Significanc	6	0

Population analysed: 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.

Primary outcome: Number of HPV Genotypes Isolated by HIV Status

Time frame: Up to 18 months. Number. Unit: participants

Measure	HIV Positive n = 96	HIV Negative n = 19	HIV Unknown n = 4
1 HPV Genotype	44	14	1
2 HPV Genotype	12	1	2
3 HPV Genotype	9	2	0
4 HPV Genotype	4	0	0
5 HPV Genotype	5	0	0
6 HPV Genotype	3	0	0
7 HPV Genotype	5	0	0
8 HPV Genotype	1	0	0

Population analysed: 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.

Primary outcome: Commonest HPV Genotypes Isolated by HIV Status

Time frame: 18 months. Number. Unit: Participants

Measure	HIV Positive n = 101	HIV Negative n = 21
HPV 11	46	10
HPV 6	33	9
HPV 89	19	0
HPV 61	16	0
HPV 55	12	0
HPV 62	12	0
HPV 81	9	0
HPV 16	8	0

Adverse events

Time frame: 1 year and 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Positive	0 of 123 (0%)	28 of 123 (22.8%)	Not reported
HIV Negative	0 of 29 (0%)	5 of 29 (17.2%)	Not reported
HIV Unknown	0 of 4 (0%)	0 of 4 (0%)	Not reported

Limitations and caveats (from the sponsor): Thirty (19.2%) specimens had to be rejected due to contamination that occurred during the analysis process. During the HPV DNA analysis, there were protocols for different aspect of controls during the analysis which needed to be negative.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Genital Warts

Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shahila Tayib, MBChB principal investigator

University of Cape Town

Lynette Denny principal investigator

University of Cape Town

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Genital Warts and Human Papilloma Virus, run by University of Cape Town at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HPV DNA and HIV Status (time frame: 18 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01192282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.