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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
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 ]

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 ]
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Measure Type Primary
Measure Title Number of HPV Genotypes Isolated by HIV Status
Measure Description Number of HPV Genotypes isolated according to HIV Status
Time Frame Up to 18 months  
Safety Issue No  

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.
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.

Reporting Groups
  Description
HIV Positive Participants with HIV Positive
HIV Negative Participants with HIV Negative
HIV Unknown Participants who Refused HIV Testing

Measured Values
   HIV Positive   HIV Negative   HIV Unknown 
Participants Analyzed 
[Units: Participants]
 96   19   4 
Number of HPV Genotypes Isolated by HIV Status 
[Units: Participants]
     
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 
9 HPV Genotype   1   0   0 
11 HPV Genotype   2   0   0 
15 HPV Genotype   1   0   0 
No Genotype Isolated but B-Globin Positive   9   2   1 

No statistical analysis provided for Number of HPV Genotypes Isolated by HIV Status



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


  Serious Adverse Events


  Other Adverse Events


  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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