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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 ]

Measure Type Primary
Measure Title HPV DNA and HIV Status
Measure Description HPV DNA Positivity and HIV Status
Time Frame 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.
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.

Reporting Groups
  Description
HIV Positive Number of participants with HIV Positive
HIV Negative Number of participants with HIV Negative
HIV Unknown Number of participants who refused HIV Testing

Measured Values
   HIV Positive   HIV Negative   HIV Unknown 
Participants Analyzed 
[Units: Participants]
 101   21   4 
HPV DNA and HIV Status 
[Units: Participants]
     
HPV Positive   96   19   4 
HPV Negative   5   2   0 

No statistical analysis provided for HPV DNA and HIV Status



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

Measure Type Primary
Measure Title HPV DNA and Pap Smear Results
Measure Description Relationship between HPV DNA Positivity and Pap Smear Results
Time Frame 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.
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.

Reporting Groups
  Description
HPV DNA Positive Participants with HPV DNA Positive
HPV DNA Negative Participants with HPV DNA Negative

Measured Values
   HPV DNA Positive   HPV DNA Negative 
Participants Analyzed 
[Units: Participants]
 118   7 
HPV DNA and Pap Smear Results 
[Units: Participants]
   
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 

No statistical analysis provided for HPV DNA and Pap Smear Results



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

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 ]

Measure Type Primary
Measure Title Commonest HPV Genotypes Isolated by HIV Status
Measure Description 10 commonest types of HPV isolated according to HIV status
Time Frame 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.
No text entered.

Reporting Groups
  Description
HIV Positive Number of participants with HIV Positive
HIV Negative Number of participants with HIV Negative

Measured Values
   HIV Positive   HIV Negative 
Participants Analyzed 
[Units: Participants]
 101   21 
Commonest HPV Genotypes Isolated by HIV Status 
[Units: Participants]
   
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 
HPV 18   8   0 
HPV 45   8   0 

No statistical analysis provided for Commonest HPV Genotypes Isolated by HIV Status




  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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Shahila Tayib
Organization: Groote Schurr Hospital / University of Cape Town
phone: 0060195773376
e-mail: syarq@yahoo.com



Responsible Party: Shahila Tayib, University of Cape Town
ClinicalTrials.gov Identifier: NCT01192282     History of Changes
Other Study ID Numbers: 131/2010
Study First Received: August 31, 2010
Results First Received: December 15, 2012
Last Updated: January 18, 2013
Health Authority: South Africa: Human Research Ethics Committee