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

History of Changes

Results First Received: December 15, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Genital Warts Human Papilloma Virus
Intervention:	Procedure: Medical / Surgical Treatment

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No Applicable.

Reporting Groups

	Description
Number of Participants	Participants with Genital Warts

Participant Flow: Overall Study

	Number of Participants
STARTED	156
COMPLETED	156
NOT COMPLETED	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
New Cases	Newly diagnosed cases of genital warts
Recurrent Cases	Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
Persistent Cases	The warts presence after completion of treatment
Total	Total of all reporting groups

Baseline Measures

	New Cases	Recurrent Cases	Persistent Cases	Total
Overall Participants Analyzed [Units: Participants]	94	40	22	156

Age, Customized [Units: Years] Mean (Full Range)	28.64 (15 to 53)	30.18 (18 to 49)	29.91 (17 to 50)	29.21 (15 to 53)

Gender [Units: Partcipants]
Female	94	40	22	156
Male	0	0	0	0

Marital Status [Units: Participants]
Single, Not Sexually Active	19	6	5	30
Single, Sexually Active	56	27	9	92
Married	13	4	4	21
Separated / Divorced / Widow	6	3	4	13

Age at First Sexual Intercourse [Units: Participants]
14 or Less (Years)	9	2	1	12
15 - 19 (Years)	69	33	14	116
20 and Above (Years)	16	5	6	27
Virgo Intacta (Years)	0	0	1	1

Education Level [Units: Participants]
Primary	13	0	3	16
Secondary	67	36	13	116
Tertiary	14	4	6	24

Smoking [Units: Participants]
Yes	9	3	4	16
No	77	34	15	126
Previously	8	3	3	14

HIV Status [Units: Participants]
Positive	71	36	16	123
Negative	21	3	5	29
Unknown	2	1	1	4

Treatment Modalities [Units: Participants]
Local Ablation with Tricholoroacetic Acid (TCA)	7	2	2	11
Electrocautery under LA	68	28	13	109
Electrocautery / Laser Ablation under GA	17	9	7	33
TCA + Electrocautery	2	1	0	3

Outcome Measures

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1. Primary:

HPV DNA and HIV Status [ Time Frame: 18 Months ]

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2. Primary:

HPV DNA and Pap Smear Results [ Time Frame: 18 Months ]

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3. Primary:

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

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4. Primary:

Commonest HPV Genotypes Isolated by HIV Status [ Time Frame: 18 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	1 year and 10 months
Additional Description	Adverse event here referred to developement of warts recurrent after treatment.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
HIV Positive	Participants with Genital Warts who were HIV Positive
HIV Negative	Participants with Genital Warts who were HIV Negative
HIV Unknown	Participants with Genital Warts whom HIV Status was Unknown

Other Adverse Events

	HIV Positive	HIV Negative	HIV Unknown
Total, Other (not including serious) Adverse Events
# participants affected / at risk	28/123 (22.76%)	5/29 (17.24%)	0/4 (0.00%)
Skin and subcutaneous tissue disorders
Warts Recurrence ^* 1 [3]
# participants affected / at risk	28/123 (22.76%)	5/29 (17.24%)	0/4 (0.00%)
# events	28	5	0

*	Events were collected by non-systematic assessment
1	Term from vocabulary, Others
[3]	Patients recruited were seen at 3 and 6 months post-treatmeant to assess warts recurrence.

Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

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