Typing of Human Papilloma Virus (HPV) From Female Genital Warts
This study has been completed.
Sponsor:
University of Cape Town
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
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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
Hide Participant Flow
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
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 | |
|---|---|---|---|---|
|
Number of Participants
[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
Show All Outcome Measures
| 1. Primary: | HPV DNA and HIV Status [ Time Frame: 18 Months ] |
| 2. Primary: | HPV DNA and Pap Smear Results [ Time Frame: 18 Months ] |
| 3. Primary: | Number of HPV Genotypes Isolated by HIV Status [ Time Frame: Up to 18 months ] |
| 4. Primary: | Commonest HPV Genotypes Isolated by HIV Status [ Time Frame: 18 months ] |
Serious Adverse Events Other Adverse Events
| 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
| 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. |