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

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ClinicalTrials.gov Identifier: NCT01192282
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : January 15, 2013
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Shahila Tayib, University of Cape Town

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

  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 
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

1.  Primary:   HPV DNA and HIV Status   [ Time Frame: 18 Months ]
  Show Outcome Measure 1

2.  Primary:   HPV DNA and Pap Smear Results   [ Time Frame: 18 Months ]
  Show Outcome Measure 2

3.  Primary:   Number of HPV Genotypes Isolated by HIV Status   [ Time Frame: Up to 18 months ]
  Show Outcome Measure 3

4.  Primary:   Commonest HPV Genotypes Isolated by HIV Status   [ Time Frame: 18 months ]
  Show Outcome Measure 4


  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.


  More Information